EUCTR2004-002391-42-CZ
Active, not recruiting
Not Applicable
A randomized, open-label phase II. study evaluating the efficacy and safety of FOLFOX6+Cetuximab versus FOLFIRI+Cetuximab as first line therapy in patients with metastatic colorectal cancer
CECOG (Central European Cooperative Oncology Group)0 sites150 target enrollmentApril 4, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- first line therapy in patients with metastatic cancer
- Sponsor
- CECOG (Central European Cooperative Oncology Group)
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed written informed consent
- •Male or female more or equal 18 years of age
- •Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- •Metastatic colorectal carcinoma not suitable for curative\-intent resection
- •Availability of tumor sample (or able and willing to provide tumor sample)
- •for EGFR assessment
- •Presence of at least one lesion measurable unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area)
- •ECOG performance status less than 2
- •White blood cell count more or equal 3\.0 x 109/L with neutrophils more or equal 1\.5 x 109/L, platelet count more or equal 100 x 109/L, and hemoglobin more or equal 9 g/dL.
- •Bilirubin level either normal or less or equal 1\.5 x ULN
Exclusion Criteria
- •Brain metastasis (known or suspected)
- •Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is \> 6 months.
- •Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •Any investigational agent(s) within 4 weeks prior to entry
- •Previous exposure to EGFR\-pathway targeting therapy
- •Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
- •Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- •Pre\-existing neuropathy \> grade 1
- •Known grade 3 or 4 allergic reaction to any of the components of the treatment.
Outcomes
Primary Outcomes
Not specified
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A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX6 + Cetuximab versus FOLFIRI + Cetuximab as first-line therapy in patients with metastatic colorectal cancerEUCTR2004-002391-42-HUCECOG (Central European Cooperative Oncology Group)150