Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALpanitumumab
Sponsors
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed