- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006468
Comparing Two Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the efficacy of intermittent high-dose oxaliplatin in combination with a simplified bimonthly regimen of leucovorin calcium (LV) and fluorouracil (5-FU) vs standard dose oxaliplatin in combination with the standard bimonthly regimen of LV and 5-FU in patients with metastatic colorectal cancer.
- Determine the time to treatment failure, tolerance, response rate, and overall survival in patients treated with these 2 regimens.
- Compare quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to treatment center, performance status (0-1 vs 2), and number of metastatic sites (1 vs more than 1). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1, and leucovorin calcium IV over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2.
- Arm II: Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours followed by 5-FU IV over 46 hours beginning on day 1 for courses 1-6 and 19-24. For courses 7-18, patients receive leucovorin calcium IV followed by 5-FU IV as above beginning on day 1.
Courses repeat every 14 days in both arms in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after courses 4 and 6, and every 6 courses thereafter.
Patients are followed monthly for 3 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 460 patients (230 per treatment arm) will be accrued for this study within 18 months.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75571
- Hopital Saint Antoine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed unresectable metastatic adenocarcinoma of the colon or rectum
Bidimensionally measurable or evaluable disease outside previously irradiated area
- No bone metastasis as target lesion
- At least 1 cm if spiral CT scan OR
- At least 2 cm if conventional CT scan
- No CNS metastasis
- No symptomatic ascites or pleural effusion that is not evacuated
- No total or partial bowel obstruction
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- ECOG 0-2
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Alkaline phosphatase less than 5 times upper limit of normal (ULN)
Renal:
- Creatinine less than 3 times ULN
- No uncontrolled hypercalcemia
Cardiovascular:
- No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias
Other:
- No peripheral sensory neuropathy
- No prior significant neurologic or psychiatric disorders
- No other malignancy within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
- No active infection
- No other concurrent serious disease
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for metastatic disease
Chemotherapy:
- Prior adjuvant chemotherapy allowed, provided progression-free interval of more than 6 months since end of last course
- No prior oxaliplatin or irinotecan
- No prior chemotherapy for metastatic disease
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No concurrent radiotherapy
Surgery:
- Concurrent surgery allowed
Other:
- At least 30 days since other prior investigational drugs
- No other concurrent investigational treatment
- No other concurrent antitumoral treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Aimery de Gramont, MD, Hopital Saint Antoine
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Calcium
- Levoleucovorin
Other Study ID Numbers
- CDR0000068282
- FRE-GERCOR-OPTIMOX-2000
- EU-20034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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