Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: FOLFIRI regimen Drug: FOLFOX regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal carcinoma
- Metastatic disease
- Not amenable to surgery
- Unidimensionally measurable disease
- No bone metastases
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- WHO 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present)
- SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present)
Renal
- Creatinine no greater than 1.25 times ULN
Cardiac
- No concurrent cardiac abnormalities that would preclude study therapy
Pulmonary
- No concurrent pulmonary abnormalities that would preclude study therapy
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No chronic enteropathy
- No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer
- No concurrent severe uncontrolled infection
- No obstruction or partial obstruction that would interfere with study therapy
- No psychological, social, familial, or geographical situation that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent anticancer biological response modifiers
Chemotherapy
- No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago)
- No prior irinotecan
- No prior oxaliplatin
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent anticancer hormonal therapy
Radiotherapy
- At least 4 weeks since prior pelvic radiotherapy
- No prior abdominopelvic radiotherapy
Surgery
- At least 4 weeks since prior surgery
- No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines)
Other
- No other concurrent experimental medication
- No other concurrent anticancer therapy
Contacts and Locations| France | |
| Centre Hospitalier de L' Agglomeration Montargoise | |
| Amilly, France, 45207 | |
| Pole Sante Sarthe et Loir Hopital Pierre Daguet | |
| Angers, France, 49036 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Regional Francois Baclesse | |
| Caen, France, 14076 | |
| Clinique Sainte-Marguerite | |
| 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 | |
| Polyclinique Francheville | |
| Perigueux, France, 24004 | |
| Centre Eugene Marquis | |
| Rennes, France, 35062 | |
| CHG Roanne | |
| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00066274 History of Changes |
| Other Study ID Numbers: | CDR0000315384, FRE-FNCLCC-ACCORD-08/0103, EU-20233 |
| Study First Received: | August 6, 2003 |
| Last Updated: | January 10, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV colon cancer stage IV rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Irinotecan Camptothecin |
Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013