Combination Chemotherapy in Treating Patients With Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00039208|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 13, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin||Phase 2|
- Determine the role of peak delivery time on the tolerability of irinotecan when administered with chronomodulated fluorouracil, leucovorin calcium, and oxaliplatin as first- or second-line therapy in patients with locoregional or metastatic colorectal cancer.
- Determine the antitumor activity of this regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0-1 vs 2), and line of treatment (first vs second). Patients are randomized to receive irinotecan at 1 of 6 different times of the day.
Patients receive irinotecan IV over 6 hours on day 1 and fluorouracil IV and leucovorin calcium IV over 11 hours followed by oxaliplatin IV over 11 hours on days 2-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A maximum of 186 patients (31 per irinotecan administration time) will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||August 2005|
- Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy
- Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy, excluding those who stopped prior to course 3 for reasons other than toxicity
- Peak delivery time for CPT11 activity over the first 3 courses
- Peak delivery time for CPT11 tolerability and efficacy over the first 6 courses
- Severe toxic events assessed by CTC v2.0 after each course of chemotherapy
- Progression-free survival
- Overall survival
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): NCT00039208
|Study Chair:||Carlo Garufi, MD||Istituti Fisioterapici Ospitalieri - Roma|