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Sponsors and Collaborators: |
Albany Medical College National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004257 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil plus radiation therapy in treating patients who have primary esophageal or stomach cancer.
Condition | Intervention | Phase |
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Esophageal Cancer |
Drug: fluorouracil Drug: oxaliplatin Procedure: conventional surgery Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil.
Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously on days 8-42. Patients also undergo radiotherapy once daily, 5 days a week, for 6 weeks beginning on day 8.
Patients without evidence of distant disease or unresectable local regional invasion undergo esophageal resection between days 63-70 (within 3-4 weeks after completion of chemoradiotherapy). Patients then receive oxaliplatin as above on days 105, 119, and 133 and fluorouracil as above on days 105-147.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil 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.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within approximately 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or gastroesophageal (GE) junction
Supraclavicular lymph nodes at station 1 must be less than 1.5 cm or nonpalpable by physical examination
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Lawrence P. Leichman, MD | Albany Medical College |
Study ID Numbers: | CDR0000067504, ALB-RPCI-DS-99-08, RPCI-DS-99-08, NCI-T99-0061 |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004257 History of Changes |
Health Authority: | United States: Federal Government |
stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
Antimetabolites Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Squamous Cell Carcinoma Immunosuppressive Agents Carcinoma Oxaliplatin Digestive System Diseases |
Esophageal Disorder Fluorouracil Stomach Neoplasms Head and Neck Neoplasms Epidermoid Carcinoma Gastrointestinal Neoplasms Stomach Cancer Esophageal Diseases Carcinoma, Squamous Cell Adenocarcinoma |
Antimetabolites Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Esophageal Neoplasms Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Oxaliplatin Digestive System Diseases Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases |