Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV rectal cancer, stage IV colon cancer, recurrent rectal cancer, recurrent colon cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer Biopsy-accessible metastatic disease Measurable disease No CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic WBC ≥ 4,000/mm^3 OR Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL No bleeding disorder Hepatic Bilirubin ≤ 1.5 mg/dL Albumin ≥ 2.5 g/dL Renal Creatinine ≤ 1.5 mg/dL Urine protein:creatine ratio < 1.0 Cardiovascular Blood pressure ≤ 150/100 mmHg No arterial thrombotic event within the past 6 months No New York Heart Association grade II-IV congestive heart failure Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after completion of study treatment No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other malignancy with < 10% chance of relapse within 3 years No uncontrolled infection No severe uncontrolled illness that would preclude study participation No peripheral neuropathy interfering with function No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months No serious non-healing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No concurrent sargramostim (GM-CSF) Chemotherapy No prior chemotherapy, including oxaliplatin, for metastatic disease Prior adjuvant oxaliplatin allowed provided disease progressed > 12 months after completion of oxaliplatin At least 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) No more than 2 courses of prior mitomycin No concurrent chemotherapy Endocrine therapy No concurrent anticancer hormonal therapy Radiotherapy At least 2 weeks since prior radiotherapy No prior radiotherapy to > 15% of bone marrow No concurrent radiotherapy Surgery At least 4 weeks since prior major surgery At least 1 week since prior minor surgery Other Recovered from prior therapy No prior epidermal growth factor receptor inhibitor therapy No other concurrent antineoplastic or antitumor therapy No other concurrent investigational agents
Sites / Locations
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- UHHS Chagrin Highlands Medical Center
Arms of the Study
Arm 1
Experimental
Erlotinib, modified FOLFOX6, and bevacizumab