Status:
COMPLETED
Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gi...
Detailed Description
OBJECTIVES: * Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in patients with epidermal growth factor receptor-positive metastatic unresectable colorectal cancer. * Co...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic colorectal cancer
- Unresectable disease
- Primary tumor or metastases must be epidermal growth factor receptor-positive by immunohistochemistry
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by CT scan
- Measurable lesion must not be in a previously irradiated area
- No prior or current CNS metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- WHO 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin normal
- Renal
- Creatinine clearance \> 50 ml/min
- Cardiovascular
- No New York Heart Association class III or IV congestive heart failure
- No symptomatic coronary artery disease
- No uncontrolled cardiac arrhythmia
- No myocardial infarction within the past 12 months
- No other significant cardiac disease
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 12 months after study participation
- Negative pregnancy test
- No peripheral neuropathy of any origin \> grade 1 (e.g., alcohol or diabetes)
- No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication
- No severe reaction attributed to fluoropyrimidine therapy
- No known hypersensitivity to fluorouracil or any other component of the trial drugs
- No known dihydropyrimidine dehydrogenase deficiency
- No other medical condition (e.g., uncontrolled diabetes or active autoimmune disease), geographical situation, or psychiatric disorder that would preclude study compliance
- No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for advanced or metastatic cancer
- At least 6 months since prior adjuvant chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- At least 30 days since prior experimental drugs
- No other concurrent experimental drugs
- No concurrent drugs that are contraindicated for use with the trial drugs
- No other concurrent anticancer therapy
- No concurrent sorivudine or any of its chemically-related analogues (e.g., lamivudine)
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00227734
Start Date
June 1 2004
End Date
February 1 2006
Last Update
June 5 2012
Active Locations (18)
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1
Kantonspital Aarau
Aarau, Switzerland, 5001
2
Hirslanden Klinik Aarau
Aarau, Switzerland, CH-5001
3
Praxis Dr. Streit
Baden, Switzerland, 5404
4
Kantonsspital Baden
Baden, Switzerland, CH-5404