Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00217711|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 5, 2012
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) 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 irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Capecitabine Drug: irinotecan hydrochloride Drug: oxaliplatin||Phase 1 Phase 2|
- Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I)
- Determine the efficacy of this regimen in these patients. (Phase II)
- Determine the tolerability of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of capecitabine followed by a phase II study.
- Phase I: Patients receive oxaliplatin IV over 2 hours on days 1 and 15, irinotecan IV over 1 hour on days 8 and 22, and oral capecitabine twice daily on days 1-29. Treatment repeats every 5 weeks for up to 6 courses 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 capecitabine at the MTD and irinotecan and oxaliplatin as in phase I.
After completion of study treatment, patients are followed every 2 months for 1 year and then every 4 months thereafter.
PROJECTED ACCRUAL: A total of 23-32 patients (3-12 for the phase I portion and 20 for the phase II portion) will be accrued for this study within 2.75 years
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oxaliplatin, Irinotecan, and Capecitabine as a Combination Regimen for First-Line Treatment of Advanced or Metastatic Colorectal Cancer|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||October 2011|
Active Comparator: Arm A
Oxaliplatin, Irinotecan, and Capecitabine
Drug: irinotecan hydrochloride
- capecitabine + oxaliplatin + irinotecan dose finding [ Time Frame: 30 days ]Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I)
- Efficacy of Oxaliplatin, Irinotecan, and Capecitabine [ Time Frame: 2 months ]Determine the efficacy of this regimen in these patients (Phase II)
- Objective response (CR or PR) as measured after completion of study treatment [ Time Frame: 2 months ]
- Adverse events as measured after completion of study treatment [ Time Frame: 2 months ]
- Time to progression [ Time Frame: life-long ]
- Time to treatment failure as measured after completion of study treatment [ Time Frame: life-long ]
- Overall survival [ Time Frame: life-long ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217711
|Chur, Switzerland, CH-7000|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Hirslanden Klinik Aarau|
|Lausanne, Switzerland, CH-1011|
|City Hospital Triemli|
|Zurich, Switzerland, CH-8063|
|Study Chair:||Razvan Popescu, MD||Centre Hospitalier Universitaire Vaudois|