Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed colon or rectal cancer Metastatic or unresectable disease Unidimensionally measurable disease required for phase II only At least 20 mm by x-ray, CT scan, MRI, or photography The following are not considered measurable: Pleural effusion or ascites Osteoblastic lesions Evidence of disease on bone scan alone Progressive irradiated lesions alone Bone marrow involvement Brain metastases Malignant hepatomegaly by physical exam alone Chemical markers (e.g., carcinoembryonic antigen) Recurrent disease after surgery or radiotherapy is considered measurable as long as the following criteria are met: At least 4 weeks since prior surgery or radiotherapy Measurable disease exists outside the radiation port or clear progression exists within the radiation port Tissue accessible for immunohistochemical evidence of epidermal growth factor receptor expression from a metastatic site (phase II only) No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No unstable angina pectoris No symptomatic congestive heart failure No cardiac arrhythmia No uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg) Opthalmic No abnormalities of the cornea (e.g., severe dry eye syndrome or Sjogren's syndrome) No congenital abnormality (e.g., Fuch's dystrophy) No abnormal slit-lamp examination using vital dye (e.g., fluorescein or Bengal-Rose) No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear-production test) Mild dry eye syndrome allowed if patient can use artificial tears and ophthalmologist concurs Gastrointestinal No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation No active peptic ulcer disease Other Must be able and willing to undergo a mediport insertion Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except previously excised and inactive basal cell or squamous cell skin cancer No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib or other study drugs (e.g., epidermal growth factor inhibitors like cetuximab) No significant traumatic injury within the past 3 weeks No peripheral neuropathy grade 2 or greater No ongoing or active infection No other uncontrolled concurrent illness that would preclude study entry No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Phase I: Prior chemotherapy allowed Phase II: No prior chemotherapy for metastatic disease Prior adjuvant therapy allowed if disease progresses during adjuvant therapy No prior oxaliplatin Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics More than 3 weeks since prior major surgery and recovered No prior surgical procedures affecting absorption Other No other concurrent investigational agents No other concurrent anticancer agents or therapies (commercial or investigational) No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Memorial Sloan-Kettering Cancer Center