Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: panitumumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: panitumumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer