Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With Metastatic Colorectal Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- 1-year survival (phase II) [ Designated as safety issue: No ]
- Progression-free survival (phase II) [ Designated as safety issue: No ]
- Overall survival in (phase II) [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of capecitabine when given in combination with oxaliplatin and gefitinib in patients with metastatic colorectal cancer. (phase I)
- Determine the response rate in patients treated with this regimen. (phase II)
- Determine the safety and toxic effects of this regimen in these patients.
- Determine the 1-year survival of patients treated with this regimen. (phase II)
- Determine the progression-free and overall survival of patients treated with this regimen. (phase II)
OUTLINE: This is an open-label, nonrandomized, phase I, dose-escalation study of capecitabine followed by a phase II study.
- Phase I: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive oral gefitinib once daily beginning 5 days before the initiation of capecitabine and oxaliplatin and continuing for the duration of study treatment. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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.
- Phase II: Patients receive oral capecitabine (at the MTD determined in phase I), oxaliplatin IV, and oral gefitinib as in phase I.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087334
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Marwan Fakih, MD||Roswell Park Cancer Institute|