Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)

Inclusion Criteria:

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 Criteria:

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