Status:
COMPLETED
Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work in different ways ...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with celecoxib, capecitabine, and irinotecan. Secondary * Det...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Locally recurrent or metastatic disease
- Measurable disease, defined as ≥ 1 measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan
- Bone metastases, ascites, and pleural effusion are not considered measurable disease
- Measurable lesions must be located outside a previously irradiated field
- PATIENT CHARACTERISTICS:
- Performance status
- SWOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin normal
- No Gilbert's disease
- Renal
- Creatinine clearance \> 50 mL/min
- Cardiovascular
- No clinically significant cardiac disease that is not well controlled by medication, including any of the following conditions:
- Congestive heart failure
- Symptomatic coronary artery disease
- Cardiac arrhythmias
- No myocardial infarction within the past year
- Gastrointestinal
- Must have a physically intact upper gastrointestinal tract
- Able to swallow tablets
- No history of peptic ulcer disease or gastroesophageal reflux
- No malabsorption syndrome
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No asthma, urticaria, or allergic-type reaction after prior treatment with aspirin or other nonsteroidal anti-inflammatory drugs
- No other malignancy except curatively treated cancer with no evidence of active disease
- No unresolved bacterial infection requiring antibiotics
- No other serious infection
- No known allergy to study drugs or sulfa drugs
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for colorectal cancer
- Patients relapsing \> 6 months after completion of prior adjuvant chemotherapy allowed
- No other concurrent anticancer chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy
- No concurrent anticancer radiotherapy
- Surgery
- Recovered from prior surgery
- No concurrent anticancer surgery
- Other
- Prior celecoxib for nonmalignant disorders allowed
- No other concurrent cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory drugs, including any of the following:
- Rofecoxib
- Ibuprofen
- Naproxen
- Etodolac
- Oxaprozin
- Diflunisal
- Nabumetone
- Tolmetin
Exclusion
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00258232
Start Date
January 1 2002
End Date
August 1 2007
Last Update
April 8 2013
Active Locations (3)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0944
2
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
3
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240