Status:
TERMINATED
Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer
Lead Sponsor:
AIO-Studien-gGmbH
Collaborating Sponsors:
iOMEDICO AG
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this interventional study is to investigate whether there is evidence that panitumumab in combination with XELOX (capecitabine plus oxaliplatin) chemotherapy will safely increase progre...
Detailed Description
Subjects with metastatic colorectal cancer with KRAS-wildtype will be randomized in a 1:1 ratio to receive a 2nd line treatment regimen of panitumumab plus oxaliplatin and capecitabine (XELOX) or XELO...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 years or more, with histologically or cytologically-confirmed and radiologically-measurable metastatic colorectal cancer.
- One prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine and irinotecan based chemotherapy. Subjects must have disease progression (as assessed by the investigator) and must be no candidates for primary metastasectomy.
- Measurable disease according to RECIST 1.1 guidelines. All sites of disease must have been evaluated within 28 days prior to registration / randomization, and diagnosed by the investigator.
- Liver and kidney function within defined ranges and sufficient bone marrow reserve.
Exclusion
- Central nervous system metastases, or significant cardiovascular disease.
- Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR tyrosine kinase inhibitors (e.g. erlotinib).
- Prior treatment with oxaliplatin for metastatic disease. Adjuvant therapy with oxaliplatin based combination for non-metastatic disease is allowed if terminated \> 6 months prior to initiation of screening and without progression during the treatment with oxaliplatin.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00950820
Start Date
September 1 2009
End Date
March 1 2012
Last Update
March 4 2013
Active Locations (1)
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1
AIO-Studien-gGmbH
Berlin, State of Berlin, Germany, 10623