A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Participants' chemotherapy will be given once a week for two weeks in a row, with a rest
period on the third week. This three week period of time is called a cycle.
Week 1 (Cycle 1): The nurse in the infusion clinic will start an intravenous line to give
premedications, fluid and the chemotherapy. Bevacizumab is only given on day 1 of each
cycle and is infused over 90 minutes. Docetaxel, cisplatin and irinotecan will each be
given over 30 minutes.
Week 2 (Cycle 1): The following tests and procedures will be performed prior to the
administration of chemotherapy; blood tests, height, weight, vital signs, review of
medications and any side effects. Once the tests and procedures are complete, docetaxel,
cisplatin and irinotecan will each be administered over 30 minutes.
If the participants' cancer is still present in the esophagus or stomach, the doctor will
offer the option of reevaluating the tumor with endoscopy. The doctor will look for signs
that the tumor is dying and any evidence of bleeding. A biopsy will be done during this
Week 1 (Cycle 2 and all future cycles): On day one of each cycle the participant will
undergo the following: Medical history and physical exam including vital signs; blood
tests; bevacizumab, docetaxel, cisplatin and irinotecan infusions.
Week 2 (Cycle 2 and all future cycles): The following tests and procedures will be
performed: blood tests; vital signs; side effect evaluation; docetaxel, cisplatin and
After every 2 cycles of chemotherapy, a urinalysis to test for protein in the urine, and CT
scans to measure the tumor will be performed.
Participants will be in this research study for at least 2 cycles. After the CT scan, if
the study doctor thinks this regimen of chemotherapy is helping and the tumors are stable or
shrinking, the participant can continue on the study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the 10-month progression-free survival for the combination of TPC plus bevacizumab in this patient population and to compare this result to the 10-month progression-free survival with TPC alone in these patients
Peter Enzinger, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|