Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
NCT00411450 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2016-02-15
Summary
The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.
Conditions
Interventions
- BIOLOGICAL
-
Panitumumab
Administered by intravenous infusion
- DRUG
-
Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2009-01-31
- Completion
- 2010-10-31
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