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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Sanofi-Aventis Genentech |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00390416 |
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.
Condition | Intervention | Phase |
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Stomach Neoplasms Esophageal Neoplasms |
Drug: Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma |
Estimated Enrollment: | 44 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Primary Objective
Secondary Objectives
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematologic (minimal values):
Hepatic (minimal values):
Kidney function (minimal values):
The patient has a PT (INR) < or = 1.5 and a PTT < or = 3 seconds above the upper limits of normal if the patient is not on anticoagulation therapy. If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
Exclusion Criteria:
Significant cardiac disease defined as:
Contact: Minaxi Jhawer, MD | 212-639-3113 | jhawerm@mskcc.org |
Contact: Manish Shah, MD | 212-639-3113 | shah1@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center 1275 York Avenue | Recruiting |
New York, New York, United States, 10021 | |
Principal Investigator: Minaxi Jhawer, MD | |
Sub-Investigator: Manish Shah, MD |
Principal Investigator: | Minaxi Jhawer, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center ( Minaxi Jhawer, MD ) |
Study ID Numbers: | 06-096 |
Study First Received: | October 17, 2006 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00390416 |
Health Authority: | United States: Institutional Review Board |
Metastatic Gastroesophageal Docetaxel Cisplatin |
Fluorouracil Bevacizumab Metastatic Gastroesophageal Adenocarcinoma |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Leucovorin Stomach cancer Bevacizumab Carcinoma Docetaxel Digestive System Diseases |
Stomach Diseases Cisplatin Fluorouracil Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Esophageal neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Vitamin B Complex Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Vitamins Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Micronutrients |