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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00040859 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer Gastric Cancer |
Drug: capecitabine Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia |
Study Start Date: | September 2002 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR.
Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy).
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A maximum of 44 patients will be accrued for this study within 26 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 gastric cardia for which no potentially curative or significant palliative therapy exists
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, Iowa | |
Mercy Medical Center - Sioux City | |
Sioux City, Iowa, United States, 51104 | |
Siouxland Hematology-Oncology Associates, LLP | |
Sioux City, Iowa, United States, 51101 | |
St. Luke's Regional Medical Center | |
Sioux City, Iowa, United States, 51104 | |
United States, South Dakota | |
Sanford Cancer Center at Sanford USD Medical Center | |
Sioux Falls, South Dakota, United States, 57117-5039 | |
Medical X-Ray Center, PC | |
Sioux Falls, South Dakota, United States, 57105 | |
Avera Cancer Institute | |
Sioux Falls, South Dakota, United States, 57105 |
Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
Study ID Numbers: | CDR0000069413, NCCTG-N0149 |
Study First Received: | July 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00040859 |
Health Authority: | United States: Federal Government |
stage IV gastric cancer recurrent gastric cancer stage III esophageal cancer stage IV esophageal cancer |
recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
Capecitabine Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Stomach cancer 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 Pharmacologic Actions |