- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00072553
Celecoxib, Leucovorin, Fluorouracil, and Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin, fluorouracil, and oxaliplatin in treating patients who have metastatic colorectal cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic colorectal cancer treated with celecoxib, leucovorin calcium, fluorouracil, and oxaliplatin.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the time of disease control to evaluate progression-free survival in patients treated with this regimen.
- Determine the salvage surgery rate in patients treated with this regimen.
- Determine the duration of chemotherapy-free intervals in patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive FOLFOX7 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Patients also receive oral celecoxib twice daily beginning on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease stop treatment. If disease progression occurs during the chemotherapy-free interval, patients receive an additional 6 courses.
Patients with responding disease after receiving at least 6 courses of chemotherapy may undergo surgery. Beginning within 10 weeks after surgery, patients receive simplified LV5FU2 chemotherapy comprising leucovorin calcium IV over 2 hours on day 1, fluorouracil IV over 46 hours beginning on day 1, and oral celecoxib twice daily beginning on day 1. Treatment repeats every 14 days for at least 12 courses.
Quality of life is assessed at baseline, during courses 4 and 6, and then every 2 months thereafter.
Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Paris, France, 75970
- Hopital Tenon
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic disease
- Inoperable disease (i.e., not suitable for complete carcinological surgical resection)
Measurable disease or nonmeasurable disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional CT scan OR 10 mm by spiral CT scan
- Nonmeasurable disease defined as all other lesions, including small lesions or truly nonmeasurable disease
- No CNS metastases
- No exclusive bone metastases
- No symptomatic ascites or pleural effusion not evacuated before study entry
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No known significant bleeding disorder
Hepatic
- Alkaline phosphatase less than 3 times upper limit of normal (ULN)
Renal
- Creatinine less than 1.5 times ULN OR
- Creatinine clearance at least 30 mL/min
- No uncontrolled hypercalcemia
Cardiovascular
- No congestive heart failure
Gastrointestinal
- No total or partial bowel obstruction
- No active gastric or duodenal ulceration or gastrointestinal bleeding within the past year
- No active inflammatory bowel disease
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No peripheral sensory neuropathy
- No known sensitivity to celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
- No AIDS-related illness
- No active infection
- No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy for metastatic disease
Chemotherapy
- Prior adjuvant chemotherapy allowed provided the progression-free interval after completion of therapy is more than 6 months in duration
- No prior chemotherapy for metastatic disease
- No prior adjuvant oxaliplatin
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent chronic oral or IV corticosteroid use (i.e., 2 weeks or longer in duration)
Radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 30 days since prior investigational drugs
- No other concurrent investigational drugs or treatments
- No concurrent prophylactic fluconazole
No concurrent chronic full-dose aspirin (at least 325 mg/day), other nonsteroidal anti-inflammatory drugs (NSAIDs), or other cyclooxygenase (COX)-2 inhibitors
- Concurrent low-dose (cardioprotective) aspirin (80 mg/day or equivalent) allowed
- No concurrent lithium
- No other concurrent anticancer therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Quality of life
|
Tolerability
|
Time of disease control (progression-free survival)
|
Salvage surgery rate
|
Duration of chemotherapy-free intervals
|
Collaborators and Investigators
Investigators
- Study Chair: Thierry Andre, MD, GERCOR - Multidisciplinary Oncology Cooperative Group
Publications and helpful links
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
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Cyclooxygenase 2 Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Celecoxib
- Leucovorin
- Calcium
- Levoleucovorin
Other Study ID Numbers
- CDR0000340181
- GERCOR-OPTIMOX2-CELECOXIB-2002
- EU-20325
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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