Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

Esophageal Cancer Clinical Trial

Official title: A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

Status Active, not recruiting

Clinical Trial Summary

The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. Of the 40 patients on this trial, 60% of the patients showed a response of some kind and the regimen was well tolerated. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.

Clinical Trial Description

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 procedure.

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 irinotecan infusions.

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Stomach Cancer
• Stomach Neoplasms

• NCT number: NCT00394433
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2006
• Completion date: June 2016