A Randomized Phase II Study of Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy for Patients With Resectable Adenocarcinoma of the Pancreas
The Study Drugs:
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells
Erlotinib is designed to block the activity of a protein found on the surface of many tumor
cells that may control tumor growth and survival. This may stop tumors from growing.
Signing this consent form does not mean that you will be able to take part in this study.
You will have "screening tests" to help the doctor decide if you are eligible to take part
in this study. The following tests and procedures will be performed:
- You will have a complete physical exam.
- Blood (about 2 tablespoons) will be drawn for routine tests. This routine blood draw
will include a pregnancy test for women who are able to have children. To take part in
this study, the pregnancy test must be negative.
- You will be asked about any side effects you may have experienced.
- Urine will be collected for routine tests.
- You will have chest x-rays and computed tomography (CT) scans of the abdomen to check
the status of the disease.
The study doctor will discuss the screening test results with you. If the screening tests
show that you are not eligible to take part in the study, you will not be enrolled. Other
treatment options will be discussed with you.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to receive either chemotherapy without radiation (Group A) or
chemotherapy with radiation (Group B). You will have an equal chance of being in either
Pre-Surgery Study Drug Administration:
- If you are in Group A, you will receive gemcitabine over about 90 minutes 1 time each
week (Days 1, 8, 15, 22, 29, 36 [+/- 2 Days]. You will take erlotinib by mouth, with
water, 1 hour before eating or 2 hours after eating 1 time daily on Days 1-42.
- If you are in Group B, you will receive gemcitabine over about 40 minutes 1 time each
week (Days 1, 8, 15, 22, 29, 36, [+/- 2 Days]). You will take erlotinib by mouth, with
water, 1 hour before eating or 2 hours after eating 1 time daily on Days 1-42. You
will also receive radiation therapy 1 time each day for 5 days in a row (Monday through
Friday) for 5 1/2 weeks starting on Day 1. You will sign a separate consent form for
the radiation therapy. If any days of radiation therapy are missed, you will make up
the missed day(s) at the end of therapy so you receive the full amount of radiation
Post-Surgery Study Drug Administration:
For all participants, starting within 12 weeks after the surgery, you will receive
gemcitabine over 100 minutes on Days 1, 8, and 15 [+/- 2 Days]) of each 4 weeks cycle. You
will also take erlotinib by mouth with water 1 hour before eating or 2 hours after eating 1
time daily for 4 weeks.
You may be able to receive your postoperative therapy closer to home by an outside cancer
doctor. This will be up to the treating cancer doctor at M. D. Anderson. A research nurse
will contact you at least every other week by telephone. Participants who need radiation
treatment will only be allowed to receive radiation treatment at M. D. Anderson Cancer
All participants will have chest x-rays and CT scans performed approximately 4 weeks after
the last dose of the study drug combination to check the status of the disease. If the
disease has not gotten worse, and the study doctor thinks it is in your best interest, you
will be scheduled to have surgery to remove the pancreas and duodenum. You will sign a
separate consent form for the surgery.
If you are not found to be eligible for surgery, your participation on this study end at
Length of Study:
You will be taken off study early if the disease gets worse, you experience intolerable side
effects, or the study doctor thinks it is no longer in your best interest to continue to
receive the study drug. You will remain on the study for approximately 10 months.
After your participation on this study is complete, you will have a chest x-ray and a CT
scan every 4 months for 2 years.
This is an investigational study. Gemcitabine and Erlotinib are both FDA and commercially
available, but their use together with radiation therapy is investigational.
Up to 190 patients will take part in the study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Difference in positive margin resection (R1) rate in patients undergo surgery between the two treatment groups
Analysis at surgery performed 6-8 weeks preoperative therapy
Jason B. Fleming, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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