A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Treated Metastatic Colorectal Cancer
- Conditions
- metastatic colorectal cancer1001799010017991
- Registration Number
- NL-OMON29791
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Patients with adenocarcinoma of the colon or rectum, who are presenting with metastatic disease.
Received one and only one prior chemotherapy regimen consisting of fluoropyrimidine-based chemotherapy.
At least one uni-dimensionallly measurable lesion of at least 20 mm per modified RECIST criteria.
History or known presence of central nervous system metastases
History of another primary cancer (exceptions see page 32)
Prior irinotecan therapy
Prior anti-EGFr antibody therapy or treatment with small molecule EGFr inhibitors.
Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies < or = 30 days before randomization
Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for randomization.
Radiotherapy < or = 14 days prior to randomization
Active infection requiring systemic treatment or any uncontrolled infection < or = 14 days prior to randomization
Any investigational agent or therapy < or = 30 days before randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy: Overall survival (OS) and progression free survival (PFS) </p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy: overall objective response rate (ORR), time to progression (TTP),<br /><br>duration of response (DOR)<br /><br>Safety: Incidence of AE*s and significant laboratory changes</p><br>