Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00066274|
Recruitment Status : Unknown
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 7, 2003
Last Update Posted : January 13, 2009
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: FOLFIRI regimen Drug: FOLFOX regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin||Phase 2|
- Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
- Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months for 1 year.
Patients are followed at 2 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer|
|Study Start Date :||May 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066274
|Centre Hospitalier de L' Agglomeration Montargoise|
|Amilly, France, 45207|
|Pole Sante Sarthe et Loir Hopital Pierre Daguet|
|Angers, France, 49036|
|Bordeaux, France, 33076|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Hyeres, France, 83400|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, F-85025|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|CHR D'Orleans - Hopital de la Source|
|Orleans, France, 45100|
|Perigueux, France, 24004|
|Centre Eugene Marquis|
|Rennes, France, 35062|
|Roanne, France, F-42300|
|Centre Hospitalier de Rodez|
|Rodez, France, 12027|
|Centre Rene Huguenin|
|Saint Cloud, France, 92210|
|Centre Hospitalier Regional Metz Thionville|
|Thionville, France, 57126|
|Centre Hospitalier General Lucien Hussel|
|Vienne, France, 38200|
|Study Chair:||Yves Becouarn, MD||Institut Bergonié|