Clinical trial: NCT01844076
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Do You Have If You Do Not Take Part In This Research Study?

Taking part in this study may or may not make your health better. While doctors hope that quinacrine and capecitabine will be more useful against cancer compared to the usual treatment, there is no proof of this yet. We do know that the information from this study will help doctors learn more about quinacrine and capecitabine as a treatment for cancer. This information could help future cancer patients.

Your other choices may include:
Getting treatment or care for your cancer without being in a study Taking part in another study Getting no treatment
Talk to your doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT01844076
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.  
Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
Fox Chase Cancer Center and affiliated Joint Centers, The Institutional Review Boards of The Fox Chase Cancer Center and Temple University, Temple University, Temple University Health System, Inc., and its affiliates or subsidiaries and other authorized representatives of these organizations.  
The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people
A description of this clinical trial will be available on *http://www.ClinicalTrials.gov*, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. You will be given a separate form to review regarding the steps we will take to guard your privacy as part of your participation in the research study. By signing that additional authorization, you will be providing your consent to use and disclose information described in that form connected with your participation in this research study.
Clinical trial: NCT01844076
Section: Duration of Study Involvement
Subsections: How Long Will You Be In The Research Study?

You will be asked to take quinacrine and capecitabine as long as you are benefitting from treatment. After you are finished treatments, the research study will involve long-term follow-up. We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking on your condition every year helps us look at the long-term effects of the study.
Clinical trial: NCT01844076
Section: Participant's Rights
Subsections: What Are Your Rights If You Take Part In This Research Study?

Taking part in this research study is your choice. You may choose either to take part or not to take part in the research study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT01844076
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can You Expect From Being In The Research Study?|Risks And Side Effects Related To The Capecitabine Include Those Which Are: Likely (≥ 20%)|Less Likely (5% To 19%)|Rare But Serious (< 5%)|Radiation Risk For Diagnostic Imaging|Reproductive Risks|What If You Are Injured While Taking Part In This Research Study?|Risks

You may have side effects while on the research study. Everyone taking part in the research study will be watched carefully for any side effects. However, doctors don't know all the side Protocol version date: 02/04/2019

Tiredness Palmar-Plantar Erythrodyesthesia (Hand-Foot-Syndrome) Redness, tenderness, pain and possible peeling of the palms of the hands and soles of the feet. The redness looks like a sunburn. The affected area can become dry and peel with numbness or tingling developing Diarrhea - increased frequency of bowel movements with loose, watery stools Skin inflammation

Swelling of the extremities Fever Pain Irritation of the eyes Shortness of breath Loss of hair Changes in skin color or nail changes Heartburn Constipation - difficulty having a bowel movement Blood clots Headache Dizziness Difficulty falling asleep Change in mood or depression Skin redness Skin rash Dehydration - loss of water in the body which can cause weakness, dry mouth, increased thirst, dark urine, and decreased urination Bleeding Changes in taste Muscle or joint pain Pain in back, arms or legs Vision changes Cough Difficulty swallowing Abnormal sensation of the skin that may include numbness, tingling, pricking, burning, or creeping feeling on the skin Anemia (low hemoglobin, low hematocrit or low red blood cell count) Red blood cells carry oxygen and nutrients throughout the body. Symptoms that may be experienced as a result of low red blood cell counts may include feeling tired and weak, shortness of breath, increased heart rate, dizziness or lightheadedness, headache, chest pain and pale skin Leukopenia/Neutropenia: (low white blood cell count) A low white blood cell count makes it hard for you to fight off infections Thrombocytopenia (low platelet count) Platelets are important in stopping bleeding. A
low platelet count can increase the time to form a blood clot Mucositis/stomatitis- sores in the lining of your mouth and/or throat that can be painful and make it hard to swallow Nausea-feeling sick to your stomach Vomiting- throwing up Decrease or Loss of appetite Belly pain Elevated liver enzymes: Liver enzymes are proteins made by the liver that are measured in the blood, with a blood draw. Liver enzymes indicate how well your liver is functioning. Elevated liver enzymes may or may not indicate damage to your liver. You may not feel any symptoms, however higher liver enzyme levels may cause you to feel overly tired or weak, you may bruise or bleed more easily, and you may experience abdominal pain or have a yellowing of the skin or eyes

Chest pain Heart attack - symptoms may include chest pain/tightness, shortness of breath, nausea, sweating, dizziness Abnormal heart rhythm that could cause your heart beat differently (too fast or slow) –
symptoms may include make you feel tired or short of breath Stroke Difficulty breathing Clotting disorders Bowel inflammation or obstruction causing death of tissue Radiation recall reaction - a sunburn-like reaction in an area that has received radiation Death

It is unlikely that there will be any harmful effects from the radiation exposure you will receive from participating in this study.  
At high levels of exposure, scientists agree that radiation can cause cancer. At low exposure levels most scientists agree that the risk, if any, is very low. You will have low levels of radiation exposure with diagnostic imaging procedures.  
Risks from exposure to radiation may accumulate over a lifetime.

Study treatment may make you sterile (unable to have children).  
The drugs in this study may affect a baby, before or after the baby is born.  
You should not become pregnant or father a baby while on this research study because the drugs you take could possibly hurt an unborn baby.  
If you are pregnant now or if you are breast-feeding now, you may not take part in this research study.  
If you become pregnant while you are on the research study, you may not continue to take part in the research study.  
For women who can become pregnant:
You should not become pregnant while you are in this study. You should not breast-feed your baby while taking drugs for this research study.

If you are injured as a result of your participation in this research study, seek immediate medical care. Temple University Health System or its subsidiaries will treat the injury, though there is no commitment to provide monetary compensation or free medical care. Other financial compensation (such as lost wages or pain and suffering) for such injuries is not available. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small.
Clinical trial: NCT01844076
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Before You Begin The Research Study|During The Research Study Study Treatment|Tests And Procedures

You will need to have the following exams, tests or procedures to find out if you can be in the research study.  
Protocol version date: 02/04/2019 These exams, tests, or procedures are part of regular cancer care and may be done even if you do not join the research study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.  
Medical history including and medications or supplements you may be taking Physical exam Vital signs including o Heart rate or pulse o Blood Pressure o Breathing rate o Temperature Height Weight Blood Counts: (1 teaspoon of blood)
Blood Chemistry: (2 teaspoons of blood)
CEA and CA 19-9 Blood tests (about 4 teaspoons)
ECG (as needed, this is a test to measure the electrical activity of your heart) Tumor Imaging and measurements using a CT Scan or MRI
o A CT scan is a computerized x-ray that gives your study doctor pictures of the inside of your body o A MRI scan uses a magnetic field and radio waves to take pictures of the inside of your body Blood Pregnancy Test (2 teaspoons of blood)
Study Related Blood Tests Blood collection for future research (about 7 tablespoons of blood)
If you choose to agree, tissue from your tumor will be sent to Caris Life Sciences for biomarker testing and mutational analysis. Mutational analysis or testing identifies changes or abnormalities in the DNA of your cancer tissue.  
o This information will become a part of your permanent medical records, your clinical trial records and a copy of the report will be given to your study doctor.  
o Your tumor tissue may be from a previous biopsy or a new biopsy if you are scheduled to have one. You will not be asked to have a new biopsy solely for this optional tissue collection.  
o You will be asked to sign a separate consent form for this optional testing.  
o Your decision will not affect your ability to participate in this clinical research study.

Treatments will be given in a 21-day period called a cycle. On day 1 of every cycle, you will receive both study drugs, quinacrine and capecitabine.  
Both quinacrine and capecitabine are pills that are taken orally. Quinacrine should be taken after a meal with water. You will take quinacrine each day of the cycle (Days 1-21). Capecitabine should be taken within 30 minutes after a meal with water.  
You will take capecitabine days 1-14 of the cycle.
If you are in the phase I part of this study, you will have up to 6 cycles of treatment. Once the safe level of quinacrine is found in phase I, you may be able to be a part of phase 2. Your treatment may last up to a year in total. If you start in the phase 2 part you will have up to 1 year of treatments. Your study doctor will tell you your dose and how many pills of capecitabine and quinacrine to take. The capecitabine dose is based on your height and weight. You should not drink alcohol or use medicines that have alcohol in them like cough syrup or dental mouthwashes while taking the study medications.

If the exams, tests and procedures show that you can be in the research study, and you choose to take part, then you will need the following tests and procedures. They are part of regular cancer care.  
Physical exam Vital signs o Heart rate or pulse o Blood Pressure o Breathing rate o Temperature Weight Blood Counts: (1 teaspoon of blood)
Blood Chemistry: (2 teaspoons of blood)
CEA and CA 19-9 Blood tests (about 4 teaspoons) (Day 1 of every cycle) Tumor Imaging and measurements using a CT Scan or MRI (After every 3 Cycles)
o A CT scan is a computerized x-ray that gives your study doctor pictures of the inside of your body o A MRI scan uses a magnetic field and radio waves to take pictures of the inside of your body
You will need these tests and procedures that are either being tested in this research study or being done to see how the research study is affecting your body.  
Study Related Blood Tests o Pharmacokinetic (PK) study (to measure the amount of quinacrine and capecitabine in your blood. (about 2 teaspoons of blood)
This will be done several times:
Before you receive study drugs on day 1 of your first treatment 1 Hour after your first treatment 2 Hours after your first treatment 4 Hours after your first treatment 8 Hours after your first treatment Cycle 2 Day 1 Cycle 3 Day 1
Clinical trial: NCT01844076
Section: Purpose of Research
Subsections: Why Is This Research Study Being Done?

The purpose of the first part of this research study, (Phase 1) is to find the maximum dose of quinacrine and capecitabine that can be given together without causing severe or intolerable side effects. Study doctors will determine the safety and side effects of the combination of quinacrine and capecitabine in patients with advanced metastatic colorectal cancer. The purpose of the second part of this study (Phase 2) is to see how well patients being treated with quinacrine and capecitabine respond to treatment. We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. We can use what we learn from this research study to help other people with the same disease.
Clinical trial: NCT01844076
Section: Withdrawal from Study
Subsections: Can You Stop Being In The Research Study?|Can You Be Removed From This Research Study?

Yes. Your participation in this research is completely voluntary. If you agree to participate now and change your mind later, you may withdraw at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely and will discuss with you options for withdrawal such as continuing to provide further data collection from routine medical care. .

The study doctor may stop you from taking part in this research study at any time if he/she believes it is in your best interest; if you do not follow the research study rules; or if the research study is stopped.