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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019773 |
Purpose
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 I trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have colorectal, appendix, or small bowel cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma of the Appendix Colorectal Cancer Small Intestine Cancer |
Drug: capecitabine Drug: oxaliplatin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients |
| Study Start Date: | July 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive oxaliplatin IV over 2 hours on day 1 followed by oral capecitabine twice daily on days 1-5 and 8-12. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of capecitabine 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 3 months for 6 months.
PROJECTED ACCRUAL: A total of 106 patients will be accrued for this study within 36 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Eva Szabo, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000067201, NCI-99-C-0117, MB-NAVY-99-01, NCI-T99-0011 |
| Study First Received: | July 11, 2001 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00019773 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer stage 0 colon cancer stage 0 rectal cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer |
stage IV rectal cancer recurrent colon cancer recurrent rectal cancer small intestine adenocarcinoma small intestine lymphoma small intestine leiomyosarcoma recurrent small intestine cancer carcinoma of the appendix |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Rectal Diseases Ileal Diseases Duodenal Neoplasms Oxaliplatin Neoplasms by Site Ileal Neoplasms Jejunal Diseases Therapeutic Uses Duodenal Diseases |
Jejunal Neoplasms Capecitabine Digestive System Neoplasms Neoplasms by Histologic Type Intestinal Diseases Pharmacologic Actions Intestinal Neoplasms Carcinoma Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |