A Phase II Study of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), and Leucovorin (CF) in Patients With Metastatic Colorectal Carcinoma Previously Treated With Irinotecan (CPT-11)
Overview
- Phase
- Phase 2
- Intervention
- FOLFOX regimen
- Conditions
- Colorectal Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 40
- Locations
- 24
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil and leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with irinotecan. 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.
Detailed Description
OBJECTIVES: I. Determine the tumor response rate in patients treated with oxaliplatin, fluorouracil, and leucovorin calcium for metastatic colorectal cancer previously treated with irinotecan. II. Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with this regimen. III. Determine the toxicity of this regimen in this patient population. IV. Assess the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during treatment, and then after the last course of treatment. Patients are followed every 3 months for 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during treatment, and then after the last course of treatment.
Intervention: FOLFOX regimen
Arm I
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during treatment, and then after the last course of treatment.
Intervention: fluorouracil
Arm I
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during treatment, and then after the last course of treatment.
Intervention: leucovorin calcium
Arm I
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium and fluorouracil IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response for 2 consecutive courses may discontinue study treatment at the investigators discretion. Quality of life is assessed at baseline, approximately every 6-8 weeks during treatment, and then after the last course of treatment.
Intervention: oxaliplatin
Outcomes
Primary Outcomes
Not specified