Preop Chemoradiation Resectable Pancreas
1. To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.
- To assess disease free survival and overall survival
- To assess margin resection rate (R0 vs. R1) in these patients
- To assess patterns of failure
Drug: Avastin (Bevacizumab)
Procedure: Radiation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Pilot Study of Preoperative Gemcitabine and Bevacizumab-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreas|
- Number of Patients with Resection [ Time Frame: 8 weeks (+/- 2 days) after the completion of chemoradiation ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + Avastin + Surgery
Gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy
Drug: Avastin (Bevacizumab)
10mg/kg by vein (IV) on Days 1, 2, 15 and 29 the adjuvant therapy every two weeks starting approximately 6 weeks after surgery for three months.
Other Names:Drug: Gemcitabine
400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)
Other Names:Procedure: Radiation Therapy
Day 3 +/-2 days (Monday) Start Radiation therapy, Mon -Fri x 28 days; 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions)
Hide Detailed Description
Gemcitabine is designed to disrupt the growth of the cancer cells, which causes the cancer cells to start to die.
Avastin is designed to prevent or slow down the growth of tumors by its damaging effects on blood vessel growth in tumors.
Before treatment starts, you will have a complete physical exam. Blood (about 2 tablespoons) will be drawn for tests, and a urine test will be performed. Chest x-rays and computed tomography (CT) scans of the abdomen will be done. Women who are able to have children must have a negative blood (1-2 tablespoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive gemcitabine once a week, Avastin once every 2 weeks, and radiation 5 times a week. Gemcitabine and Avastin will be given on Saturdays, and the radiation will be given Monday through Friday of each week. You will receive this treatment as an outpatient for 6 weeks.
You will receive gemcitabine through a needle in a vein on Days 1, 8, 15, 22, 29, and 36 (+/- 2 days). You will receive Avastin through a needle in a vein every 2 weeks on Days 1, 15, and 29 (+/- 2 days). On the days you receive both drugs, you will receive Avastin over 30-90 minutes and gemcitabine over 40 minutes.
The first dose of Avastin will be given over about 90 minutes. If you do not have a reaction (such as fever/chills), the next dose will be given over about 60 minutes, and if again no reaction occurs, each dose after that will be given over about 30 minutes. If you experience a reaction to the Avastin infusion, you may be given acetaminophen (such as Tylenol) by mouth and/or diphenhydramine (Benadryl) by vein over 30 minutes before each dose to decrease the risk of further reactions.
Radiation will be given Monday through Friday for 5 1/2 weeks. Each day of treatment, you will lie on a treatment table. The radiation therapist will help position your body so that the radiation goes to the right place. A machine will deliver the radiation. It will take about 15-20 minutes to receive the radiation treatment each day.
If any days of radiation are missed, these days will be made up at the end of your treatment (at the end of 28 days) so that you receive the full amount of radiation.
During the study, you will have physical exams weekly while you are receiving chemoradiation, every other week while you are receiving chemotherapy after surgery, and every 4 months during the follow-up period. You will have blood drawn (1-2 tablespoons each time) for routine tests on a weekly basis while you are receiving chemoradiation, every other week while you are taking Avastin after surgery for 3 months, and every 4 months during the follow-up period. The possible development of side effects will be closely monitored and could require extra blood and/or urine samples. You may also have physical exams, blood and urine tests, x-rays, and scans after completing the chemoradiation part of the study, depending upon what is medically needed for evaluation of ongoing therapy.
The overall effect of treatment will be evaluated at least 8 weeks (+/- 2 days) after the completion of chemoradiation. A chest x-ray and CT scans of the chest, abdomen, and pelvis will then be performed, and blood (about 2 tablespoons) will be drawn for routine tests. Some participants will have surgery to remove part of the pancreas, if needed. The reason to wait at least 8 weeks is to allow a safe period of time to pass after the last dose of Avastin to prevent bleeding during surgery. It may also help decrease the risk of postoperative complications, including bleeding and poor wound healing.
This research study allows participants to receive up to 3 infusions of Avastin during the chemoradiation part of the study. If the treatment is shown to benefit you, your doctor may continue to give additional infusions of Avastin every 2 weeks (+/- 2 days) for 3 months after surgery. After the Avastin treatment, you will have a chest x-ray, abdominal CT scan, and blood (about 2 tablespoons) will be drawn for routine tests every 4 months after surgery for 2 years to check the status of the tumor.
This is an investigational study. The study drugs are commercially available and FDA approved, but their use together with radiation is experimental. Avastin is FDA approved for colon and lung cancers but has not been evaluated by the FDA for pancreatic cancer. Gemcitabine is FDA approved for pancreatic cancer. Avastin will be provided free of charge during the study, however the cost of the infusion of the drug will be the responsibility of you and/or your insurance company. The costs of gemcitabine and radiation are considered standard of care, and will be the responsibility of you and/or your insurance company. Up to 31 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336648
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Douglas Evans, MD||M.D. Anderson Cancer Center|