EUCTR2011-003217-41-AT
Active, not recruiting
Phase 1
Biomarker directed treatment in metastatic colorectal cancer - AGMT_ERCC1
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 sites50 target enrollmentDecember 6, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Untreated wild\-type RAS metastatic colorectal cancer patients
- •Previous adjuvant therapy must have been completed \= 1 year before therapy initiation.
- •Measurable disease with CT or MRI
- •ECOG performance status of 0\-2
- •Adequate tissue to evaluate for genotyping
- •Adequate organ function
- •Hematologic:
- •Absolute neutrophil count \> 1,500/µL
- •Hemoglobin \>9 mg/dl
- •Platelet count \>100,000 /µl
Exclusion Criteria
- •Creatinine clearance of below 30 ml/min
- •Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent.
- •Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina.
- •Other known co\-morbidity with the potential to dominate survival
- •Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
- •Pregnant or breast feeding women
- •Any co\-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Outcomes
Primary Outcomes
Not specified
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