NCT00390416

Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma

A Phase II Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to find out what effects a drug named/called bevacizumab has on patients and patients' tumors when given together with standard chemotherapy drugs. Making new blood vessels seems to be important for many tumors to grow. Bevacizumab is a new type of treatment for cancer that blocks the growth of new tumor blood vessels. In this study, the researchers will combine bevacizumab with chemotherapy drugs that are standard for the patient's disease and include cisplatin, docetaxel, fluorouracil, and leucovorin. The way the original combination of cisplatin, docetaxel, and fluorouracil was given caused many side effects including gastrointestinal symptoms, weakness, and a drop in the blood count of infection fighting cells. For this study, the researchers have modified this combination to give lower doses of the medicines more often, to reduce side effects from the chemotherapy. Patients will receive bevacizumab with this modified combination of docetaxel, cisplatin, and fluorouracil. This study is called a phase II study. In this study, everyone will have similar tumors and receive the same treatment.

Conditions

• Stomach Neoplasms
• Esophageal Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin	Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2006-10-19
• Last updated: 2016-03-14
• Results posted: 2016-03-14

Locations

5 sites across 1 country: United States