Sorafenib, Cetuximab, and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal Cancer
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer
About this trial
This is an interventional treatment trial for Recurrent Colon Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed colorectal cancer (advanced or metastatic disease not amenable to potential curative resection) Archival tumor (blocks and/or slides) must be available for patients who decline tumor biopsies Tumor must be amenable to sequential biopsies for patients willing to undergo tumor biopsy Must have evidence of disease progression after first-line chemotherapy for advanced disease Previously irradiated lesions are not considered measurable disease Measurable disease, defined as >= 1 unidimensionally measurable target lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan No known brain metastases Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100% Life expectancy of more than 12 weeks white blood cell count (WBC) >= 3,000/mm^3 Bilirubin normal Creatinine normal OR creatinine clearance >= 60 mL/min No hypertension No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Able to swallow oral medication Willing to undergo 2 sequential tumor and skin biopsies No ongoing or active infection No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No prior cetuximab No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF) or epoetin alfa At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No other concurrent chemotherapy More than 4 weeks since prior radiotherapy and recovered No prior sorafenib No other prior therapy targeted against MAPK More than 14 days since prior and no concurrent administration of the following cytochrome P450 3A4 (CYP3A4) inducers: Rifampin Rifabutin Hypericum perforatum (St. John's wort) Phenytoin Carbamazepine Phenobarbital More than 7 days since prior and no concurrent administration of the following CYP3A4 inhibitors: Amiodarone Clarithromycin Diltiazem Erythromycin Grapefruit juice Indinavir Saquinavir Lopinavir in combination with ritonavir Fosamprenavir Ritonavir Atazanavir Nelfinavir Itraconazole Ketoconazole Nefazodone No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapy Negative pregnancy test Fertile patients must use effective contraception Absolute neutrophil count >=1,500/mm^3 Platelet count ≥ 100,000/mm^3 No evidence of bleeding diathesis Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times upper limit of normal
Sites / Locations
- University of Colorado at Denver Health Sciences Center
- Johns Hopkins University
Arms of the Study
Arm 1
Experimental
Treatment (sorafenib, irinotecan, cetuximab)
Patients will receive sorafenib by mouth once or twice a day and a 1- to 2-hour infusion of cetuximab once a week for 8 weeks. They will also receive a 1½-hour infusion of irinotecan once a week in weeks 3-6. Patients will then receive sorafenib by mouth once or twice a day and a 1- to 2-hour infusion of cetuximab once a week for 6 weeks. They will also receive a 1½-hour infusion of irinotecan once a week in weeks 1-4. Treatment may repeat every 6 weeks for as long as benefit is shown.