Clinical trial: NCT00780494
Section: Alternatives
Subsections: We Cannot And Do Not Guarantee Or Promise That You Will Receive Any Benefits From This Study. Alternatives

There are other experimental and non-experimental treatments besides the one described in this study at this or other institutions. You may choose to receive other investigational drugs (if available). All alternative experimental and nonexperimental therapies have similar or increased risks and side effects. You may also decide not to have any further treatment. In this case, you would receive supportive care to make you as comfortable as possible. You should discuss the alternatives with your doctor before you make your decision about taking part in this study.
Clinical trial: NCT00780494
Section: Confidentiality
Subsections: Confidentiality|Use And Disclosure Of Protected Health Information Authorization To Use Your Health Information For Research Purposes

Your identity will be kept as confidential as possible as required by law. Except as required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier. Your research records may be disclosed outside of Stanford, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to research study personnel. The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed.  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |  
Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction. The purpose of this research study is to obtain data or information on the safety and effectiveness of study treatment; the results will be provided to the sponsor, the Food and Drug Administration and other federal and regulatory agencies as required.

Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.
Clinical trial: NCT00780494
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

We think you will be in the study for at least 9-18 weeks. If the treatment appears beneficial to you, you may continue to receive it for a longer time. If you go off the study for any reason, we would like to keep track of your medical condition for approximately 3 years. If you receive treatment longer than 3 years, we will continue to monitor you.
Clinical trial: NCT00780494
Section: Participant Responsibilities
Subsections: Subject'S Responsibilities

You should:
Take the study drug as instructed.  
Keep your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.  
Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.  
Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.  
Keep the study drug in a safe place, away from children and for your use only.  
Keep your diaries as instructed.  
Complete your questionnaires as instructed.  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |  
Ask questions as you think of them. Tell the Protocol Director or research staff if you change your mind about staying in the study.  
Follow the instructions of the protocol Director and study staff.
While participating in this research study, you should not take part in any other research project without approval from all of the Protocol Directors. This is to protect you from possible injury arising from such things as extra blood drawing, extra x-rays, the possible interaction(s) of research drugs, or other similar hazards.
Clinical trial: NCT00780494
Section: Participant's Rights
Subsections: Subject'S Rights|Experimental Subject'S Bill Of Rights

You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director. You will still receive care for your disease and will not lose any benefits to which you would otherwise be entitled. You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.

As a human subject you have the following rights. These rights include but are not limited to the subject's right to:
be informed of the nature and purpose of the experiment;  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |  
be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; be given a description of any attendant discomforts and risks reasonably to be expected; be given an explanation of any benefits to the subject reasonably to be expected, if applicable; be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits; be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise; be given an opportunity to ask questions concerning the experiment or the procedures involved; be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.
YOUR SIGNATURE INDICATES THAT YOU HAVE READ AND UNDERSTAND THE ABOVE INFORMATION, THAT YOU HAVE DISCUSSED THIS STUDY WITH THE PERSON OBTAINING CONSENT, THAT YOU HAVE DECIDED TO PARTICIPATE BASED ON THE INFORMATION PROVIDED, AND THAT A COPY OF THIS FORM HAS BEEN GIVEN TO YOU.
Clinical trial: NCT00780494
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks.|Possible Risks, Discomforts, And Inconveniences|Possible Risks From Capecitabine|Possible Risks From Carboplatin|Possible Risks From Bevacizumab|Rare But Serious:|Possible Risks From Blood Draws|Possible Risk Of Ct Contrast

Disease testing raises certain questions about informing you of any results. Possible risks of knowing results include: anxiety. A possible risk of not knowing includes being unaware of the need for treatment.  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
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| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |

There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions. While on the study, you are at risk for side effects from capecitabine, carboplatin, and bevacizumab. They may cause some, all or none of the side effects listed. The drug combination may cause unknown side effects. Many side effects go away shortly after treatments are stopped, but, in some cases, side effects can be serious or long lasting or permanent. In addition there is always the risk of a very rare or previously unknown side effect (or even death) occurring. If any of these side effects occur, you must tell your doctor who may prescribe medications to ease the discomfort you may experience. In addition, if a severe reaction to the drug occurs, your doctor may discontinue the study treatment.

The common side effects of capecitabine are:
Fatigue Pain, swelling, numbness, tingling, or redness of the hands or feet Skin infection Skin discoloration Diarrhea, Nausea, vomiting, stomatitis (mouth sores)
Numbness, tingling in hand and foot area Rare side effects:
Lowering of the white blood cells and red blood cells Other abnormal blood tests Fever Headache, dizziness, difficulty sleeping Loss of hair Eye irritation, vision abnormal Difficulty breathing Chest pain Abdominal pain, stomach or intestinal discomfort or bleeding, Constipation Loss of appetite, dehydration, taste disturbance Swelling in hands, feet, abdomen Back pain, joint pain Mood alteration, depression  
Approval Date: March 19, 2013  
Protocol Director:Pamela Kunz, M. Expiration Date: March 19, 2014  
Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma ep 11911 Blood clots in deep vein

The common side effects of carboplatin are: Lowering of the white blood cell and red blood cells Low platelets with risk of bleeding and decreased ability for clotting Fatigue, weight loss Loss of appetite Nausea, vomiting Mouth sores, taste disturbances Abnormal blood tests Rare side effects:
Decreased hearing, mild ringing in the ears, problems with balance Alteration in the rhythm of the heartbeat High blood pressure Inflammation or blood clots in a vein Fever Pain, swelling, numbness, tingling, or redness of the hands or feet Injection site reaction Rash Constipation Diarrhea, dehydration Trouble sleeping, depression Pain: abdominal, joint, bone, chest, headache, muscle pains Eye irritation, abnormal vision Inability to pass urine, renal failure Cough, difficulty breathing, hiccoughs Loss of hair

The common side effects of bevacizumab are:
Chills Rash Mild elevation in blood pressure Mild occasional nose bleeding Rare side effects:
Fever Infection Mouth ulceration  
Approval Date: March 19, 2013  
Protocol Director:Pamela Kunz, M. Expiration Date: March 19, 2014  
Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma ep 11911 Headache Severe high blood pressure Blood clot formation: which can include heart attack, stroke, or pulmonary emboli
(blood clots that have been carried through the blood into the pulmonary artery, the main blood vessel from the heart to the lung, or one of its branches, plugging that vessel).  
Severe bleeding or hemorrhage Kidney damage Colon wall perforation (Formation of a hole in the intestine)
Gallbladder perforation Heart failure Problem healing wounds Ovarian failure and impaired fertility in premenopausal women

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) or similar leukoencephalopathy syndrome: RPLS is a medical condition related to leakiness of blood vessels in the brain and can cause confusion, blindness or vision changes, seizure and other symptoms, as well as changes in brain scans. This condition is usually reversible if treated promptly, but in rare cases, it is potentially life-threatening or permanent and may have long-term effect on the brain function.  
Fistulae formation (abnormal connection or passageway between two epitheliumlined organs or vessels that normally do not connect).

The blood samples taken for this study are also associated with risks and discomforts that may include redness, warmth, redness, pain, bruising or infection at the site from which blood is taken.

Although rare, the intravenous (IV) contrast material involved in some CT scans causes medical problems or allergic reactions in some people. Most reactions are mild and result in hives or itchiness. In rare instances, an allergic reaction can be serious and potentially life-threatening. Make sure to tell your doctor if you've ever had a prior reaction to contrast material during medical tests.
Clinical trial: NCT00780494
Section: Procedures
Subsections: Study Treatment (Please See Attached Calendar, Appendix A)|Description Of Laboratory And Imaging Procedures|Tissue Sampling For Genetic Testing, Other Testing, Or Banking For Future Research Introduction.

This study is a Phase II study, which means that we will evaluate safety and effectiveness. All patients enrolled will receive standard doses of capecitabine, carboplatin, and bevacizumab. During the study treatment period, you will be given two intravenous (through a vein in your arm) drugs on Day 1 and take pills on Days 1 through 14 over a 21 day period. A 21 day period is called one "cycle." These cycles will be repeated as long as your cancer is responding to treatment and you are tolerating chemotherapy without serious side-effects.  
**Capecitabine** is a pill that is swallowed twice daily for the first 14 days of every 21 day cycle.  
**Carboplatin** is an intravenous drug given over 30-60 minutes on the first day of every 21 day cycle.  
**Bevacizumab** is an intravenous (given through a vein in your arm) drug given over 30-90 minutes on the first day of every 21 day cycle.  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |  
Laboratory and Imaging **Procedures**: Please note that participation in the research CT Perfusion portion of your standard CT is optional; a separate consent form is available. If you have had a previous reaction to contrast agents, or a history of severe allergies or kidney disease, please inform the person obtaining your consent. Before entering the study:
Physical exam and medical history Routine blood (approx 3 teaspoons) and urine tests (considered standard clinical care)
CT scans Pregnancy test (for women of childbearing potential)
An additional 2 teaspoons of blood will be drawn and stored for future tests\
Research CT Perfusion (optional) which will be incorporated into regular CT scan.  
You will only have one scan and we will get both standard and perfusion images together.  
During the study:
Physical exam and medical history on the first day of cycle Blood (approx 3 teaspoons) and urine tests on the first day of each cycle CT scans (chest, abdomen and pelvis) every 3 cycles An additional 2 teaspoons of blood will be drawn on the first day of each cycle and stored for future tests Research CT Perfusion (optional) after 3 cycles only and incorporated into regular CT scan.  
End of study:
You will be asked to return to the clinic approximately 30 days after the last dose of medication for the following procedures: Physical examination and medical history Blood (approx 3 teaspoons) and urine tests. CT scans After the study:
After the end-of-treatment visit, you will enter the long-term follow-up period of the study. We would like to follow you for at least 3 years after discontinuing the study. You will be followed in the clinic at least every year. All of the following tests and procedures are routine, considered standard of care for evaluating cancer therapy: Physical exam and medical history CT scans  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |

The collection of a **blood sample** requires your blood (approximately 3 teaspoons) be removed by inserting a needle into a vein in your arm. The side effects of taking a blood sample include pain or bruising at the site of the needle puncture of your skin. The collection of a **urine sample** requires that your urine (approximately 2 tablespoons) be collected in a standard specimen jar. There are no side effects of collecting a urine sample. A **Computed Tomography (CT) scan** uses special X-ray equipment to take multiple images from different angles around the body. A computer then processes the information from the images and produces an image that shows a cross section of the area being examined. To help visualize the process, imagine looking at one end of a loaf of sliced bread. If you pull a slice out of the loaf, you can see the entire surface of that slice, from the outer crust to the center. The body is seen on CT scan "slices" in a similar way, from the outer skin to the central part of the body. The exam produces multiple slices showing multiple views of the area being examined. The "slices" can be displayed on a video monitor and saved on film for analysis. The image can be made even clearer by using a special contrast agent, which can be swallowed as a liquid, injected into a vein, or given as an enema. If you have had a previous reaction to contrast agents or a history of severe allergies, please notify the operator/investigator.

Research using tissues (in this study-blood and urine) is an important way to try to understand human disease and/or the role genes play in disease. You have been given this consent form because the investigators want to include your blood and urine in a research project, or because they want to save such samples for research. In addition to the blood and urine samples collected as part of standard clinical care we will be collecting additional blood samples for future research studies.
Clinical trial: NCT00780494
Section: Purpose of Research
Subsections: Purpose Of Research|What Is The Purpose Of This Research Study And How Will My Health Information Be Utilized In The Study?

You are invited to participate in a research study of capecitabine, carboplatin and bevacizumab in the treatment of advanced cancers in the lower esophagus and stomach. At Stanford, we currently use capecitabine and carboplatin for the treatment of these diseases and would like to study the addition of bevacizumab to this standard treatment. Bevacizumab (commercially marketed as Avastin) is currently approved by the Food and Drug Administration (FDA) for the treatment of colon, breast and lung cancer. This study is experimental because, while we know that capecitabine, carboplatin, and bevacizumab can be helpful in these other cancers, we do not yet know if this combination is helpful and safe when given to patients with cancers in the lower esophagus and stomach. This study aims to establish the safety and tolerability of the combination of capecitabine, carboplatin, and bevacizumab in patients with cancers in the lower esophagus and stomach. We also want to find out what possible benefit this combination of drugs might have of treating your cancer. You were selected as a possible candidate because you have an advanced cancer of the lower esophagus and stomach.  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |  
Your **participation** in this study is entirely voluntary. Your decision whether or not to participate will not prejudice you or your medical care. If you decide to participate, you are **free to withdraw** your consent, and to discontinue participation at any time without prejudice to you or effect on your medical care. If you decide to terminate your participation in this study, you should notify Dr. George Fisher at (650) 725-9057 or Dr. Pamela Kunz at (650) 725-1755. This research study is looking for 35 people with advanced cancers of the lower esophagus or stomach. Stanford University expects to enroll all of the research study subjects.

The purpose of this study is to investigate the safety and tolerability of the combination of capecitabine, carboplatin, and bevacizumab in patients with cancer of the lower esophagus and stomach. We also want to find out what possible benefit this combination of drugs might have of treating your cancer.  
Your identity will be kept as confidential as possible as required by law, but absolute confidentiality cannot be guaranteed. Except as required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier. Your research records may be disclosed outside of Stanford, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to research study personnel.  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |  
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed. Patient information may be provided to Federal and other regulatory agencies as required, including IRB, Genentech, and representatives or designees. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.
Clinical trial: NCT00780494
Section: Withdrawal from Study
Subsections: Right To Withdraw.|Withdrawal From Study

You have the right to refuse to allow your tissues to be studied now or saved for future study. You may withdraw from this study at any time. The investigators might retain the identified samples, e.g., as part of your routine clinical care, but not for additional research.

If you first agree to participate and then you change your mind, you are **free to** withdraw your consent and discontinue your participation at any time. Your decision will not affect your ability to receive medical care for your disease and you will not lose any benefits to which you would otherwise be entitled. If you withdraw from the study, or the study medication is stopped for any reason, you will still be asked to return to the clinic. You may be asked to undergo a physical exam or blood laboratory tests. If you experienced any side effects from the study medication, you will be followed once a week for 4 weeks, and subsequently at 4 week intervals for 3 years until the side effect resolves. These visits are important to make sure that there are no lingering side effects of having taken the study medications. All study-related supplies, including unused study drug, must be returned. The Protocol Director may also withdraw you from the study and the study medication may be stopped without your consent for one or more of the following reasons:  
The cancer worsens.  
New information on treating cancers of the lower esophagus and stomach becomes available.  
Failure to follow the instructions of the Protocol Director and/or study staff. The Protocol Director decides that continuing your participation could be harmful to you.  
Pregnancy. You need treatment not allowed in the study. The study is cancelled.  
Other administrative reasons.  
Unanticipated circumstances.  
| STANFORD UNIVERSITY Research Consent Form                                                                                                                                   | IRB USE ONLY Approval Date: March 19, 2013   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Protocol Director:Pamela Kunz, M.                                                                                                                                           | Expiration Date: March 19, 2014              |
| Protocol Title: A Phase II Study of Capecitabine, Carboplatin and Bevacizumab for Metastatic or Unresectable Gastroesophageal  Junction and Gastric Adenocarcinoma ep 11911 |                                              |