Clinical trial: NCT03714555
Section: Alternatives
Subsections: Alternative Treatment

There are other treatment options for locally advanced pancreatic cancer. These options include other chemotherapy regimens, radiation, or other experimental therapy. Your study doctor will explain the other options available to you. You do not have to participate in this study to receive treatment for your condition. You may also choose to receive no treatment for your cancer. If you decide that you don't want any more active treatment, one of your options is called "comfort care." Comfort care includes pain medication and other support. It aims to maintain your comfort and dignity rather than cure disease. Usually this care can be provided at home. If you think you might prefer comfort care, please discuss this with your family, friends and your doctor.
Clinical trial: NCT03714555
Section: Confidentiality
Subsections: Confidentiality Of Your Information Collected During The Study|Authorization To Use And Disclose Information For Research Purposes|Who Will Receive Your Personal And Medical Information Collected?

As required by the Federal Health Insurance Portability and Accountability Act (HIPAA), every effort will be made to safeguard the confidentiality of information that identifies you and relates to your past, present and future physical and mental health. We will do our best to make sure that the personal information obtained during the course of this research study will be kept private However, we cannot guarantee total privacy. Your personal information may be given out if required by law. Unless required by law, you will not be identified on any electronic form by name, social security number, address and telephone number or any other information that can directly identify you. The information shared with the sponsor is protected by the use of a code, which is a number specifically assigned to you. The study doctor is in control of the code needed to connect your data to you, but the study doctor will not send the list with the code to the sponsor. However, the study forms may contain other information about you, such as your age, sex and medical history. It is possible that this other information could be used to identify you even though your name does not appear. The results of this study may be published by the sponsor, including in a medical journal and shown at medical meetings. You will not be identified (by name or any other means, e.g., photo) in any of these publications. Because this research is regulated by the Food and Drug Administration (FDA), the FDA may inspect records related to this research, which may include your protected health information or other information about you derived or maintained as part of this study. Information derived from this study may be used for research purposes that may include publication and teaching. However, information used for publication and teaching will not disclose your identity.

What information will be collected by the study doctor and his research staff for this study? The study doctor will collect your personal and medical information. This may include:
Past and present medical records, Research records, Records about phone calls made as part of this research, Records about your study visits.  
Who may use and give out information about you? The study doctor and his research staff conducting the research.

Information from this study will be given to the study Sponsor. "Sponsor" is the person or entity that initiates, provides oversight of activities within the study, and includes any persons or companies that are contracted by the Sponsor to have access to the research information during and after the study. Medical records which identify you and the consent form signed by you will be looked at and collected for research purposes by:
Cantex Pharmaceuticals, the Sponsor, HonorHealth Research Institute, the study site Translational Genomics (TGen) Foundation, providing funding for the study.  
Your information may **be given to:**
The U.S. Food and Drug Administration (FDA),
Department of Health and Human Services (DHHS) agencies, Governmental agencies in other countries, Governmental agencies to whom certain diseases (reportable diseases) must be reported, Western Institutional Review Board (WIRB®),
HonorHealth Institutional Review Board.
The HonorHealth IRB and the HonorHealth Research Institute have the authority to review and monitor all records related to this research.  
Why will this information be used and/or given to others?  
for research purposes as described in this consent form, for consideration by the FDA or any governmental agencies in other countries for drug approval, to ensure the study was conducted as approved by the FDA and IRB,
to be used for future research purposes.
What will happen if you decide not to give permission to use and give out your private health information? You cannot be in this research study.
Clinical trial: NCT03714555
Section: Participant Responsibilities
Subsections: You Must Agree To Abstain From Ingesting Alcoholic Beverages And Alcohol-Containing Medications And Products During The Time You Are Receiving Disulfiram And For At Least 2 Weeks After Discontinuing Disulfiram.|Birth Control Requirements For Female Participants:|Birth Control Requirements For Male Participants:

Even though you may meet all the criteria for participation, it is possible that you will not be enrolled in this study. You and your doctor will decide which chemotherapy regimen is most appropriate for your disease (either protein-bound paclitaxel/gemcitabine or FOLFIRINOX). Protein-bound paclitaxel (also known as Abraxane) and gemcitabine will be given on the same day weeks 1, 2 and 3 followed by a week without treatment. This treatment will be repeated every 4 weeks (28 days) as per standard medical care. FOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-fluouracil given on the same day Weeks 1 (day 1) and 3 (day 15) every 4 weeks (28 days) as per standard medical care. Protein-bound paclitaxel, gemcitabine, oxaliplatin, irinotecan, leucovorin and 5-fluorouracil are all FDA-approved drugs. If while receiving one of these regimens, your CA 19-9 starts to rise without seeing progression in your radiographs, you will be given disulfiram-copper combination orally twice daily until you no longer respond to the treatment or the side effects determine that treatment cessation is the best course.

If you are sexually active and able to become pregnant, you must agree to use two forms of highly effective birth control methods listed below:
- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- Intrauterine device (IUD)
- Abstinence (no sex)

The study drugs may have a harmful effect on sperm. This can lead to damage to a fetus or embryo (developing unborn baby). If you are a fertile male, you must not impregnate a female while in this study. If you are sexually active, and able to father a child, you must agree to use two forms of birth control methods listed below:
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- Hormonal methods used by your partner, such as birth control pills, patches, injections, vaginal ring, or implants
- Intrauterine device (IUD) used by your partner - Abstinence (no sex)
Clinical trial: NCT03714555
Section: Participant's Rights
Subsections: Will You Have Access To The Information Collected During The Study?

To maintain the integrity of this research study, you will not have access to your personal health information related to this research until the study is complete. At the conclusion of the research and at your request, you may request access to your health information that HonorHealth maintains in a designated record set, which means a set of data that includes medical information or billing records used in whole or in part by your doctors or other health care providers at HonorHealth. If it is necessary for your care, your health information will be provided to you or your physician.
Clinical trial: NCT03714555
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Discomforts|Disulfiram-Alcohol Interaction It Is Imperative That You Avoid Alcohol-Containing Products, Foods, Drinks And Medications While On This Study And For At Least 2 Weeks After You Stop Taking Disulfiram.|Serious Side Effects With Disulfiram:|Less Serious Side Effects From Disulfiram:|Serious Side Effects With Copper Gluconate:|Common Side Effects Of Paclitaxel Protein Bound:|Rare Side Effects Related To Paclitaxel Protein Bound:|Common Side Effects Related To Gemcitabine:|Common Side Effects Related To 5-Fluorouracil:|Less Common Side Effects Related To 5-Fluorouracil:|Common Side Effects Related To Oxaliplatin:|Common Side Effects Related To Irinotecan:|Side Effects Of Palonosetron (Aloxi®):|Side Effects Of Fosaprepitant (Emend®):|Side Effects Of Dexamethasone:|Side Effects Of Ondansetron (Zofran®):|Reproductive Risks|Risks From Study Procedures:|Other Risks|Compensation For Injury

As with all investigational agents, there may be unknown risks. The study drug may not control your cancer. You may have side effects while receiving study medication. Ask the study doctor if you have any questions about the side effects described here. Side effects may be mild or severe and in rare cases, can be life-threatening. Some side effects may go away as soon as you stop taking the study drug. In some cases, side effects can be serious, lasting or may never go away. The study doctor may give you medicine(s) to help lessen any side effects. Your doctor will explain how these drugs must be taken.

Even small amounts of alcohol consumed while taking disulfiram can cause a severe reaction. Reactions typically begin within 10 to 30 minutes after alcohol is consumed and can last up to several hours. Reactions are typically proportional to the amounts of disulfiram and alcohol ingested (the more you take, the worse the reaction).  
Moderate reactions to consuming alcohol while on disulfiram may include the following:  
Sweating  Vertigo (feeling off balance) Rapid breathing  Fainting  
Difficulty breathing  Uneasiness  
Alcoholic breath odor  Confusion  
Blurred vision  Weakness Head and neck throbbing  Chest pain/palpitations  
Thirst  Low blood pressure  
Nausea  Fast heartbeat  
Vomiting  Warmth and flushing, particularly on upper chest and face Severe reactions to consuming alcohol while on disulfiram may include the following:
Slowed breathing  Seizures Sudden loss of blood flow to the brain and other vital organs Unconsciousness Irregular heartbeat  Death Heart attack (in individuals with preexisting coronary artery disease)
Sudden heart failure (affecting the chambers of the heart, in individuals with preexisting myocardial dysfunction)
Disulfiram has been approved by the FDA since 1951 for the treatment of alcoholism, therefore, many people have taken it. The potential side effects listed below are based on reports from patients who have taken disulfiram in the past.  
May 07, 2019

Alcohol intolerance An allergic reaction (swelling of your lips, tongue, or face; shortness of breath; closing of your throat; or hives)
Seizures Extreme tiredness Dark urine Yellowing of the skin or eyes (jaundice) which can be a sign of liver damage Large appetite changes Weakness, dizziness or loss of coordination Hepatitis (a disease of the liver)
Severe diarrhea or vomiting

Skin rash or acne Mild headaches Mild drowsiness or tiredness Impotence Metallic taste in the mouth; or swollen or sore tongue Increases in liver function tests

Coma Diarrhea Stomach pain and discomfort Blood in urine Low blood pressure Yellowing of the skin or eyes (jaundice)
Vomiting Less serious side effects from copper gluconate:
Metallic taste

Anemia Fatigue Hair loss (reversible)
Joint and muscle pain Low white blood cell count (which may temporarily place you at risk for infection)
Nausea Numbness, tingling or burning of hands and feet Tiredness and weakness May 07, 2019 Less common side effects related to Paclitaxel Protein Bound:
Low platelet count (which can lead to bruising or bleeding)
Appetite loss Constipation Diarrhea Edema (fluid retention)
Fever Irregular heartbeat Irritation or bruising at the site of the infusion Itching Mouth or lip sores Nail changes Vomiting

Allergic reaction Cough Difficulty breathing Congestive heart failure (the heart does not pump blood effectively) Left ventricular dysfunction (when a part of the heart, the left ventricle muscle, does not contract as well as it should which may lead to heart failure)
Kidney (abnormal function or failure)
Liver function tests abnormal Low blood pressure Pulmonary edema (fluid in lungs) Rash Visual disturbances (temporary), (flashing lights or blurry vision)

Anemia (low red blood cell count - which may cause you to feel tired, look pale, and have shortness of breath)
Constipation Diarrhea Fever Flu-like symptoms (fever, feeling tired, loss of appetite, chills and cough)
Hair loss (reversible)
Liver function tests abnormal Low platelet count (which can lead to bruising or bleeding)
Low white blood cell count (which may temporarily place you at risk for infection)
Nausea Rash Vomiting May 07, 2019 Less common side effects related to Gemcitabine:
Edema (fluid retention)
Fatigue Irritation or bruising at the site of the infusion Itching Mouth or lip sores Tingling, prickling of the skin

Diarrhea Nausea and possible occasional vomiting Mouth sores Poor appetite Watery eyes, sensitivity to light (photophobia) Taste changes, metallic taste in mouth during infusion Discoloration along vein through which the medication is given Anemia (low red blood cell count - which may cause you to feel tired, look pale, and have shortness of breath)
Low platelet count (which can lead to bruising or bleeding)
Low white blood cell count (which may temporarily place you at risk for infection)

Skin reactions: dry, cracking, peeling skin.  
Darkening of the skin (hyperpigmentation)
Hair thinning Nail changes: discoloration, loss of nails (rare)
Hand-foot syndrome (Palmar-plantar erythrodysesthesia or PPE) - skin rash, swelling, redness, pain and/or peeling of the skin of the palms of hands and soles of feet

Numbness and tingling and cramping of the hands or feet often triggered by cold Nausea and vomiting Diarrhea Mouth sores Anemia (low red blood cell count - which may cause you to feel tired, look pale, and have shortness of breath)
Low platelet count (which can lead to bruising or bleeding)
Low white blood cell count (which may temporarily place you at risk for infection)
- Fatigue - Loss of appetite

- Diarrhea - two types: early and late forms - Early diarrhea: Occurring within 24 hours of receiving drug, accompanied by symptoms runny nose, increased salivation, watery eyes, sweating, flushing, abdominal cramping. (This can occur while the drug is being administered. If so, alert your healthcare professional promptly. Medication can be given to stop and/or lessen this early side effect).  
- Late diarrhea: Occurring greater than 24 hours of receiving drug, usually peaks at about 11 days after treatment. Because of concerns of dehydration and electrolyte imbalances with diarrhea it is important to be in contact with health care professionals for monitoring, and for medication and diet modifications advice.  
- Nausea and vomiting. - Weakness - Anemia (low red blood cell count - which may cause you to feel tired, look pale, and have shortness of breath)
- Low white blood cell count (which may temporarily place you at risk for infection) - Hair loss - Poor appetite - Fever - Weight loss Less common side effects related to Irinotecan:
- Constipation - Shortness of breath - Sleep problems, insomnia  
- Cough - Headache - Dehydration - Chills - Skin rash - Flatulence, gas - Flushing of face during infusion - Mouth sores - Heartburn - Swelling of feet and ankles Rare side effects related to Leucovorin:
- Nausea and vomiting - Allergic reaction - rash, itching, facial flushing

Palonosetron will be given by IV before the paclitaxel protein bound, cisplatin and gemcitabine to prevent nausea and vomiting that you may experience.  
Less serious side effects that can occur include:
- Headache - Constipation - pain, redness swelling or a lump under your skin where the needle is placed
More serious side effects that can occur include:
- allergic reaction (symptoms include hives, swelling of the face or hands, trouble breathing, tingling in your mouth or throat and/or chest tightness)
- anxiety - restlessness - fever
- sweating
- muscle spasms - nausea and/or vomiting - diarrhea - lightheadedness, dizziness, fainting
- chest pain and/or irregular heartbeat

Fosaprepitant will be given by IV before the paclitaxel protein bound, cisplatin and gemcitabine to prevent nausea and vomiting. In addition, you may receive fosaprepitant orally to take on your own to prevent any nausea and vomiting that you may experience at home.  
May 07, 2019 Less serious side effects that can occur include:
- nausea and/or vomiting - heartburn - stomach pain - diarrhea or constipation - loss of appetite - hiccups - increased thirst or hot, dry skin - weakness, dizziness, tired feeling - headache - ringing in your ears - fever, chills, body aches, flu symptoms - sleep problems (insomnia) - pain or a hard lump where the medicine was injected.  
More serious side effects that can occur include:
- feeling light-headed - fainting - slow heart rate - pale skin, easy bruising or bleeding - pain or burning when you urinate

Dexamethasone will be given by IV before the paclitaxel protein bound, cisplatin and gemcitabine to prevent nausea and vomiting that you may experience. Less serious side effects that can occur include:
- upset stomach - stomach irritation - vomiting
- headache
- dizziness - insomnia - restlessness - depression
- anxiety
- acne - elevated blood sugars - increased hair growth - easy bruising
- irregular or absent menstrual periods More serious side effects that can occur include:
- skin rash - swollen face, lower legs, or ankles - vision problems - cold or infection that lasts a long time - muscle weakness - black or tarry stool

Ondansetron may be given in lieu or in addition to fosaprepitant to prevent/treat nausea and vomiting. Your doctor will decide what the best course of treatment is to prevent/treat any nausea/vomiting that you may experience. Less serious side effects that can occur include:
- headache - constipation - weakness - tiredness - chills - drowsiness More serious side effects that can occur include:
- blurred vision or vision loss - rash - hives - itching - swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs - hoarseness - difficulty breathing or swallowing - chest pain - shortness of breath
- dizziness, light-headedness, or fainting
- fast, slow or irregular heartbeat - agitation - hallucinations (seeing things or hearing voices that do not exist) - fever
- excessive sweating
- confusion - nausea, vomiting, or diarrhea - loss of coordination - stiff or twitching muscles
- seizures
- coma (loss of consciousness)
Additional medications not listed may be given to help treat any side effects. Please talk to your study doctor regarding any questions or concerns you may have about any side effects you are experiencing.

Women of childbearing potential are women who are biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partner is either sterile or using contraceptives. The study drugs may affect an unborn child or nursing infant. The risks to an unborn child or nursing infant are not fully known. These drugs may also cause changes to eggs in women.  
The following information is for women who are able to become pregnant:
- It is important that you do not become pregnant while in this study. If you become pregnant, you will be taken off this study.  
- You must have a negative serum (blood) pregnancy test before you start taking the study drugs.  
- If you do become pregnant or suspect you are pregnant, while you are on this study or within 30 days after the last dose of study treatment, you must notify your study doctor immediately.  
- You must not breast feed at any time you are in this study since any drugs you are taking may also affect the child.

- **Risk of Infection:** Subjects that develop a fever should notify their study doctor or the study team as soon as possible and may be asked to return to the study location for evaluation and possible treatment. If you develop a fever, you should begin taking the antibiotic provided to you at the first visit immediately. We will take reasonable safeguards to minimize known and potential risks but unknown and/or unanticipated side effects might occur. Some side effects go away when the study drugs are stopped. Others may be long lasting.  
- **Risks with Intravenous (IV) Drug Administration:** Temporary irritation and bruising may occur at the infusion site. There may also be discomfort, pain, or bruising from the needle puncture. In rare cases, an infection may also occur at the site of the needle stick.  
- **Risks of a Blood Draw:** Risks can also occur during blood draws. The risk of blood drawing may include bleeding, pain, lightheadedness, fainting, bruising, clotting, discomfort, and/or infection at the site of the needle stick. Your blood will be drawn weekly during the study. Depending on your condition, your study doctor may wish to perform additional blood draws.  
- **Electrocardiogram (ECG):** This test uses small sticky pads that are placed on your chest and limbs to measure the electrical activity of your heart. There may be mild discomfort from the sticky pads and a possibility of the skin being irritated by the adhesive on the sticky pads. Chest hair may need to be shaved prior to the placement of the sticky pads.  
- **CT (computed tomography) scans:** You may experience fear of being in a narrow or enclosed space while having a CT/MRI scan. You will be asked not to move during the test and to relax and breathe normally. A CT scan exposes you to a small dose of radiation. Although all radiation you receive builds up over your lifetime, this amount of radiation should not create a significant risk to your health. Contrast dye is usually injected when you get a CT scan. The contrast dye may cause pain or burning when it is injected, and may worsen kidney function in patients who already have kidney disease or who are dehydrated (have not had enough liquids that day). The contrast dye may also cause an allergic reaction, which could be severe and life-threatening.  
- **MRI (magnetic resonance imaging):** There are risks from an MRI if you are pregnant or have one of the following: an artificial heart valve, pacemaker, metal plate, pin, or other metallic objects in your body (including gun shot or shrapnel). You may also become anxious from lying in a tight space without moving. The MRI scan does not cause any pain and does not expose you to x-ray radiation.  
- PET (positron emission **tomography) scan:** A PET scan is an imaging technique that uses positively charged particles (radioactive positrons) to detect subtle changes in the body's metabolism and chemical activities. A PET scan provides a color-coded image of the body's function, rather than its structure. You may experience a mild skin prick when a substance called a tracer is injected into the vein. The tracer is radioactive but short lived and poses little to no risk.  
You must use birth control for the entire study and for at least 30 days after your last dose of study drug. If your partner becomes pregnant while you are on the study or within 30 days of receiving the last dose of study medication, you will need to report this to your study doctor.

There may be side effects that are not known at this time. Your condition may not get better or may get worse during this study. The dose you receive may be too low to have the best effect, or so high that it causes bad side effects. Only you should take the study drug. It must be kept out of the reach of children or anyone else who may not be able to read or understand the label.

We will make every effort to prevent study-related injuries and illness. If you are injured or become ill while you are in the study and the illness or injury is due to your participation in this study, you may go to any emergency room or urgent care facility to seek medical treatment. If it is determined that the injury or illness is not related to the research, the costs of this care may be charged to you or to your health insurer. No funds are available from HonorHealth to compensate you for a study-related injury or illness. This does not mean that you are giving up any of your legal rights. The study doctor will provide you medical care if you need it, and will also treat you for any complications that may occur during your participation in the study. If you become ill or are injured as a direct result of your participation in this study, you will be provided the reasonable and necessary treatment for that injury or illness. The bills for the injury or illness not caused by study participation may be billed to your medical insurance or to your third party or governmental programs in which you participate. The Sponsor, Cantex Pharmaceuticals, Inc., will reimburse you for any reasonable, necessary medical expenses, including hospitalization that you incur as a direct result of receiving Disulfiram-Copper combination as written in the protocol. Expense reimbursement will be determined by the Sponsor and your study doctor. The Sponsor will not provide reimbursements for injuries, illnesses, or conditions that (1) are unrelated to Disulfiram-Copper combination; (2) are related to Abraxane-Gemcitabine or FOLFIRINOX; (3) are related to the natural course of any underlying disease or treatment; (4) existed prior to Disulfiram-Copper combination administered to you on the study; or (5) related to the intake of alcohol in conjunction with disulfiram, as prohibited by the study protocol. No funds have been set aside to provide you with any other form of compensation, such as reimbursement for lost wages.
Clinical trial: NCT03714555
Section: Procedures
Subsections: Procedures

Screening Evaluation In the first part of the study, you will have an extensive evaluation of your medical condition. The purpose of this evaluation is to find out if you qualify for this research study. Screening procedures for this study are standard of care and include:
- Review and signing of the informed consent form before any study procedures can take place
- Complete medical history including pre-existing/current conditions, prior cancer therapy, and prior surgery
- Complete physical examination including height and weight
- Vital signs (blood pressure, pulse, respiratory rate, and temperature). - Tumor imaging to include a computed tomography (CT) and/or magnetic resonance imaging (MRI) scan, as well as a FDG-PET scan, if required by your physician, of your chest, abdomen, pelvis, and any other part of your body will be completed. This would include a brain scan if your study doctor determines that it is necessary. If CT/MRI and FDG-PET scans were taken within 28 days prior to receiving your first dose, new scans are not necessary.  
- Electrocardiogram (ECG) - Collect blood for laboratory tests. About 3 tablespoons will be taken for the following tests:
o Complete blood count (CBC) with differential and platelet count o Serum chemistry panel including liver and kidney function tests o Coagulation panel to include PTT and PT/INR
o CA 19-9 level o Serum pregnancy test (if applicable)
- Collect a urine sample for a urinalysis - Review all medications taken within the last 30 days
If you are eligible to participate in this study, you will be assigned a unique ID that will be used to identify you while you are participating in the study. Treatments will be administered in cycles. For the purposes of this study, each cycle will be 28 days long. During treatment with disulfiram-coper combination, you will be given a dosing diary to use to record daily when you take this investigational drug; each time you bring the investigational drug with you to the clinic, you will also need to bring the diary. The following assessments will be completed during each cycle on a specific day of the study:  
Treatment Evaluations for Each Cycle Day 1 (except where noted)
- Directed physical exam - Vital signs (blood pressure, pulse, respiratory rate, and temperature). - Measurement of weight - Body Surface Area (BSA) calculation prior to dosing - Collect blood for laboratory tests. About 2 Tbsp. will be taken for the following tests:
o Hematology: CBC with differential and platelet count o Blood chemistries (for liver and kidney function tests) o CA19-9 level (prior to Day 1 for Cycle 1) o Serum Pregnancy (if applicable)
- Collect a urine sample for a urinalysis
- Review any changes to your health since the last visit
- Review any changes to your medications since the last visit - Administer anti-nausea medication before treatment - Administer Paclitaxel Protein Bound and Gemcitabine OR
- Administer FOLFIRINOX
OR
- Gemcitabine alone - Receive disulfiram-copper combination medication and dosing diary for home use. - Return disulfiram-copper remaining drug and drug diary (after Cycle 1)
Day 8 and 15
- Directed physical exam - Only for Cycle 1 - Vital signs (blood pressure, pulse, respiratory rate, and temperature) - Only for Cycle 1 - Measurement of weight - Only for Cycle 1 - Collect blood for laboratory tests (no blood collected for labs on Day 8 if you are in the FOLFIRINOX group). About 1 tablespoonful will be taken for the following tests:
o Hematology: CBC with differential and platelet count o Blood chemistries (for liver and kidney function tests)
- Review any changes to your health since the last visit (via phone call on Day 8 if you are in the FOLFIRINOX group)
- Review any changes to your medications since the last visit (via phone call on Day 8 if you are in the FOLFIRINOX group)
- Administer anti-nausea medication before treatment - Administer Paclitaxel Protein Bound and Gemcitabine (Days 8 and 15)
OR
- Administer FOLFIRINOX (Day 15 only) - Gemcitabine (Days 8 and 15)
Clinical trial: NCT03714555
Section: Purpose of Research
Subsections: Purpose Of The Study

The purpose of the study is to test disulfiram-copper combination, an investigational product, in patients with metastatic adenocarcinoma of the pancreas who have received a minimum of 8 weeks of standard medical treatment with either protein-bound paclitaxel (Abraxane®)/gemcitabine (Gemzar®) or FOLFIRINOX (5FU, leucovorin, irinotecan, oxaliplatin combination regimen) and who have increased levels of the tumor marker CA 19-9 when there is no evidence from CT scans that your tumor is not responding to the therapy.
Clinical trial: NCT03714555
Section: Voluntary Participation
Subsections: Who Can Participate In This Study?|Voluntary Participation And Withdrawal

Up to a total of 42 patients with metastatic adenocarcinoma of the pancreas receiving either protein-bound paclitaxel/gemcitabine or FOLFIRINOX who have increased levels of the tumor marker CA 19-9 when there is no evidence from CT scans that your tumor is not responding to the therapy are expected to participate in this study. Patients will be participate in this study at HonorHealth, and it is possible that patients may participate in this study, or a similar study, at other sites.

Your participation in this study is voluntary. You may decide not to take part or you may leave the study at any time. Your decision will not cause any penalty or loss of benefits to which you are entitled. Your participation in this study may be stopped at any time by the study doctor or the Sponsor without your consent for any of the following reasons:
- your cancer becomes worse - side effects arise which prevent further study treatment - you decide to withdraw from the study  
- changes in your condition occur that lead your study doctor to believe that it would be harmful for you to receive further study treatment
- you become pregnant or fail to use adequate birth control (if you are of child-bearing potential)
- another anticancer medication is started - you cannot or will not follow the instructions for participation in the study - the study doctor decides it is in your best interest not to continue in the study.
If you leave the study before the planned final visit, you may be asked by the study doctor to have some tests or procedures done so that you leave the study safely.
Clinical trial: NCT03714555
Section: Withdrawal from Study
Subsections: Can This Authorization Be Withdrawn Or Canceled?

You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to stay in this study. When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others. Is my health information protected after it has been given to others? There is a risk that your information will be given to others without your permission. Absolute confidentiality cannot be guaranteed because of the need to give information to these parties.