Status:
TERMINATED
Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Genentech, Inc.
OSI Pharmaceuticals
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be studying the side ef...
Eligibility Criteria
Inclusion
- Patients must fulfill all of the following criteria to be eligible for study entry:
- Age 18-80
- Able to provide informed consent
- Biopsy proven unresectable metastatic adenocarcinoma of the colon or rectum
- Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer
- Radiographically measurable disease with at least one bidimensionally measurable lesion of \> 1 cm
- Prior first-line regimen must have been completed at least 4 weeks prior to study treatment
- Use of biologic agents with first-line chemotherapy permitted
- Previous adjuvant regimens must have been greater than 6 months before inclusion
- Adequate organ function including bone marrow, liver and renal function as defined by the following values: absolute neutrophil count \> 1500/microliter; Hgb \> 9 g/dL; platelets \> 90,000/microliter; International Normalized Ratio \< 1.8 (unless in therapeutic range if taking warfarin or other warfarin-derivative anticoagulants and are being monitored regularly for changes in prothrombin time or International Normalized Ratio); bilirubin \< 2 times the Upper Limit of Normal; alkaline phosphatase \< 3 times the Upper Limit of Normal; aspartate aminotransferase/alanine aminotransferase \< 5 times the Upper Limit of Normal; serum creatinine \< 1.5 times the Upper Limit of Normal
- Eastern Cooperative Oncology Group status \< 2
Exclusion
- Patients meeting any of the following criteria are ineligible for study entry:
- Prior second-line chemotherapy regimens for colorectal cancer
- Prior treatment with erlotinib or gefitinib
- Central Nervous System metastasis
- Second malignancies less than 5 years prior to enrollment. Completely resected basal or squamous cell carcinoma of the skin is allowed.
- Untreated/unresolved bowel obstruction
- Inability to take oral mediations
- HIV positive
- Pregnancy
- Other uncontrolled medical illnesses
- Current diarrhea \> grade 2
- Symptomatic angina or uncontrolled congestive heart failure
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00642746
Start Date
March 1 2008
End Date
December 1 2011
Last Update
September 26 2014
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239