Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer

NCT ID: NCT00039273

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31

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.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

panitumumab

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Joel Randolph Hecht, MD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Countries

United States

References

Meropol NJ, Berlin J, Hecht JR, et al.: Multicenter study of ABX-EGF monotherapy in patients with metastatic colorectal cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1026, 256, 2003.

Reference Type: RESULT

Other Identifiers

UCLA-0112063

Identifier Type: -

Identifier Source: secondary_id

IMMUNEX-054-0005

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2073

Identifier Type: -

Identifier Source: secondary_id

CDR0000069368

Identifier Type: -

Identifier Source: org_study_id