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Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064259 |
RATIONALE: Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs.
PURPOSE: This phase I/II trial is studying the side effects and best dose of oblimersen when given with cisplatin and fluorouracil and to see how well they work in treating patients with locally advanced, recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer Gastric Cancer |
Drug: cisplatin Drug: fluorouracil Drug: oblimersen |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Genasense (G3139) in Combination With Cisplatin and Fluorouracil in Patients With Advanced Esophageal, Gastro-Esophageal Junction and Gastric Cancer |
Study Start Date: | June 2003 |
OBJECTIVES:
OUTLINE: This is a pilot, multicenter, dose-escalation study of oblimersen.
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients are treated at the MTD.
PROJECTED ACCRUAL: Approximately 37-97 patients (3-36 for phase I and 34-67 for phase II) will be accrued for this study within 15-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or stomach
Measurable disease or clinically evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 1 prior chemotherapy regimen for advanced, recurrent, or metastatic disease
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
NYU Cancer Institute at New York University Medical Center | |
New York, New York, United States, 10016 | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 |
Study Chair: | Andreas Kaubisch, MD | Albert Einstein College of Medicine of Yeshiva University |
Study ID Numbers: | CDR0000310160, AECM-0266, NCI-5835, AECM-0302032 |
Study First Received: | July 8, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00064259 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the esophagus adenocarcinoma of the stomach squamous cell carcinoma of the esophagus stage III esophageal cancer stage IV esophageal cancer |
recurrent esophageal cancer recurrent gastric cancer stage III gastric cancer stage IV gastric cancer |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Squamous cell carcinoma Esophageal Neoplasms Stomach cancer Recurrence Carcinoma Epidermoid carcinoma Digestive System Diseases Stomach Diseases |
Cisplatin Fluorouracil Stomach Neoplasms Head and Neck Neoplasms Carcinoma, squamous cell Gastrointestinal Neoplasms Esophageal Diseases Carcinoma, Squamous Cell Adenocarcinoma Esophageal neoplasm |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |