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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084617 |
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer Gastric Cancer |
Drug: capecitabine Drug: irinotecan hydrochloride Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma |
Estimated Enrollment: | 80 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 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 gastric or gastroesophageal junction adenocarcinoma
Measurable disease
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, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Joanna M. Brell, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000365464, CASE-CWRU-010442, CASE-CWRU-1203, NCI-6449, CASE-1203, RPCI-I-38704 |
Study First Received: | June 10, 2004 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00084617 |
Health Authority: | United States: Food and Drug Administration |
recurrent gastric cancer stage III gastric cancer stage IV gastric cancer adenocarcinoma of the esophagus |
adenocarcinoma of the stomach recurrent esophageal cancer stage III esophageal cancer stage IV esophageal cancer |
Capecitabine Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Irinotecan Stomach cancer Camptothecin Recurrence Carcinoma |
Oxaliplatin Digestive System Diseases Stomach Diseases Stomach Neoplasms Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Esophageal neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |