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Sponsored by: |
Roswell Park Cancer Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00087334 |
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining capecitabine and oxaliplatin with gefitinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and gefitinib and to see how well they work in treating patients with metastatic colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: capecitabine Drug: gefitinib Drug: oxaliplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of Capecitabine (XELODA®, Roche) Plus Oxaliplatin (Eloxatin®, Sanofi) Plus ZD 1893 (IRESSA®) in the Treatment of Metastatic Colorectal Cancer |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized, phase I, dose-escalation study of capecitabine followed by a phase II study.
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 for survival.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 1-12 months; and a total of 26 patients will be accrued for the phase II portion of this study within 8-13 months.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed* colorectal cancer
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No evidence of clinically active interstitial lung disease
Other
No known peripheral neuropathy ≥ grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for metastatic disease (phase II)
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Marwan Fakih, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000373952, RPCI-I-17403, ZENECA-IRUSIRES0414 |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00087334 |
Health Authority: | United States: Federal Government |
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Gefitinib Rectal cancer Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |