Status:
COMPLETED
Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
Lead Sponsor:
NCIC Clinical Trials Group
Collaborating Sponsors:
Australasian Gastro-Intestinal Trials Group
Conditions:
Colorectal Cancer
Quality of Life
Eligibility:
All Genders
16-120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the u...
Detailed Description
OBJECTIVES: Primary * Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Metastatic disease
- Epidermal growth factor receptor (EGFR)-positive by immunochemistry
- Measurable or evaluable disease
- Not amenable to standard curative therapy
- Best supportive care is the only available option
- Must have received a prior thymidylate synthase inhibitor (e.g., fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting
- Combination therapy with oxaliplatin or irinotecan allowed
- Must have failed\* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens
- No symptomatic CNS metastases NOTE: \*Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen
- PATIENT CHARACTERISTICS:
- Age
- 16 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Absolute granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 75,000/mm\^3
- Hemoglobin ≥ 8.0 g/dL
- Hepatic
- AST and ALT ≤ 5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN
- Cardiovascular
- No uncontrolled angina
- No arrhythmias
- No cardiomyopathy
- No congestive heart failure
- No myocardial infarction\* within the past 6 months NOTE: \*Pre-treatment ECG as only evidence of infarction is allowed
- Pulmonary
- No severe restrictive lung disease
- No interstitial lung disease by chest x-ray
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment
- No active pathological condition that would preclude study participation
- No psychological or geographical condition that would preclude study compliance
- No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior cetuximab
- No prior murine monoclonal antibody therapy (e.g., edrecolomab)
- Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
- Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- Concurrent palliative radiotherapy allowed except to index lesions
- Surgery
- At least 4 weeks since prior major surgery and recovered
- Other
- No prior EGFR-targeted therapy (e.g., erlotinib or gefitinib)
- More than 30 days since prior experimental therapeutic agents
- More than 4 weeks since prior investigational agents
- No concurrent enrollment in another clinical study
- No other concurrent EGFR-targeted therapy
- No other concurrent non-cytotoxic experimental agents
Exclusion
Key Trial Info
Start Date :
December 30 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2009
Estimated Enrollment :
572 Patients enrolled
Trial Details
Trial ID
NCT00079066
Start Date
December 30 2003
End Date
February 10 2009
Last Update
August 4 2023
Active Locations (33)
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1
NHMRC Clinical Trials Centre
Camperdown, New South Wales, Australia, 1450
2
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
3
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
4
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, Canada, V3V 1Z2