Combination Chemotherapy in Treating Patients With Colorectal Cancer
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.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer|
- Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: Yes ]
- Peak delivery time for CPT11 activity over the first 3 courses [ Designated as safety issue: No ]
- Peak delivery time for CPT11 tolerability and efficacy over the first 6 courses [ Designated as safety issue: Yes ]
- Severe toxic events assessed by CTC v2.0 after each course of chemotherapy [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||February 2002|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
- 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.
|Centre Hospitalier Notre Dame - Reine Fabiola|
|Charleroi, Belgium, 6000|
|Liege, Belgium, B 4000|
|CHU Liege - Domaine Universitaire du Sart Tilman|
|Liege, Belgium, B-4000|
|Clinique Sainte Elisabeth|
|Namur, Belgium, 5000|
|Centre Hospitalier Peltzer-La Tourelle|
|Verviers, Belgium, B-4800|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Hospital Regional Universitaire de Limoges|
|Limoges, France, 87042|
|Paris, France, 75475|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Hopital Paul Brousse|
|Villejuif, France, 94804|
|Azienda Sanitaria di Bolzano|
|Bolzano, Italy, 39100|
|Universita G.D'Annunzio Di Chieti|
|Chieti, Italy, 66100|
|Ospedale San Carlo Borromeo|
|Milano (Milan), Italy, 20153|
|Azienda Ospedale S. Luigi at University of Torino|
|Orbassano, (Torino), Italy, 10043|
|Fondazione Salvatore Maugeri|
|Pavia, Italy, I-27100|
|Ospedale Oncologico Regionale|
|RIONERO in VULTURE, Italy, I-58028|
|Istituto Regina Elena|
|Rome, Italy, 00161|
|Istituto Clinico Beato Matteo|
|Vigevano, Italy, 27029|
|Hospital Fernando Fonseca|
|Amadora, Portugal, P-2700|
|Study Chair:||Carlo Garufi, MD||Istituti Fisioterapici Ospitalieri - Roma|