monoclonal antibody therapy in treating patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase ii trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer.

objectives: * determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody abx-egf. * determine the additional measures of clinical efficacy of this drug, in terms of progression-free survival, overall survival, and time to treatment failure, in these patients. * determine the safety of this drug in these patients. outline: this is a multicenter study. patients receive monoclonal antibody abx-egf iv over 1 hour weekly on weeks 1-8. treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year. projected accrual: a total of 20-100 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed colorectal carcinoma * diagnosed by fine-needle aspirate or tissue biopsy * metastatic disease * no squamous cell carcinoma * relapsed or refractory after prior chemotherapy with irinotecan and a fluoropyrimidine (i.e., fluorouracil, capecitabine, or ftorafur with or without leucovorin calcium) given concurrently or sequentially * progressive disease within 2 months of last dose of this prior chemotherapy for metastatic disease or * evidence of relapse within 12 months after last dose of adjuvant therapy * bidimensionally measurable disease * overexpression of epidermal growth factor r (egfr) by immunohistochemistry * must be 2+ or 3+ in at least 10% of evaluated tumor cells * no known brain metastases patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * absolute neutrophil count greater than 1,500/mm3 * platelet count greater than 100,000/mm3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast and alt no greater than 3 times uln * alkaline phosphatase no greater than 3 times uln renal: * creatinine no greater than 2.2 mg/dl cardiovascular: * lvef at least 45% by muga * no myocardial infarction within the past year other: * hiv negative * no other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix * no chronic medical or psychiatric condition that would preclude study * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 1 month after study prior concurrent therapy: biologic therapy: * no prior egfr-targeting agents or biological agents with antitumor activity chemotherapy: * see disease characteristics * at least 30 days since prior systemic chemotherapy * no more than 2 prior fluoropyrimidine regimens (e.g., fluorouracil and leucovorin calcium followed by capecitabine) * no other prior chemotherapy, except leucovorin calcium, for colorectal carcinoma endocrine therapy: * not specified radiotherapy: * at least 30 days since prior radiotherapy surgery: * not specified other: * at least 30 days since other prior anticancer therapy * no prior investigational drug with potential antitumor activity * no other concurrent investigational drugs

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer