Combination Chemotherapy in Treating Patients With Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00039208
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (20)
Hopital Saint-Louis
🇫🇷Paris, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Hospitalier Notre Dame - Reine Fabiola
🇧🇪Charleroi, Belgium
Clinique Saint-Joseph
🇧🇪Liege, Belgium
Clinique Sainte Elisabeth
🇧🇪Namur, Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Hopital Paul Brousse
🇫🇷Villejuif, France
Azienda Sanitaria di Bolzano
🇮🇹Bolzano, Italy
Universita G.D'Annunzio Di Chieti
🇮🇹Chieti, Italy
Ospedale San Carlo Borromeo
🇮🇹Milano (Milan), Italy
Azienda Ospedale S. Luigi at University of Torino
🇮🇹Orbassano, (Torino), Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Ospedale Oncologico Regionale
🇮🇹RIONERO in VULTURE, Italy
Istituto Regina Elena
🇮🇹Rome, Italy
Istituto Clinico Beato Matteo
🇮🇹Vigevano, Italy
Centre Hospitalier Peltzer-La Tourelle
🇧🇪Verviers, Belgium
Hospital Fernando Fonseca
🇵🇹Amadora, Portugal