A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
18 Years
75 Years
Both
Colorectal Cancer
Trial Information
A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Thierry Andre, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Authority:
United States: Federal Government
Study ID:
CDR0000340181
NCT ID:
NCT00072553
Start Date:
September 2003
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IV rectal cancer
- stage IV colon cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- recurrent rectal cancer
- recurrent colon cancer
- Colorectal Neoplasms
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