Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0203073 IMMUNEX-054.0009, NCI-G02-2115, NCT00047151

Objectives

1. Determine progression-free survival of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF, irinotecan, leucovorin calcium, and fluorouracil.
2. Determine additional measures of clinical efficacy of this regimen in these patients.
3. Determine the safety of this regimen in these patients.
4. Determine the pharmacokinetics of monoclonal antibody ABX-EGF when administered with this regimen in these patients.
5. Determine the pharmacokinetics of irinotecan and its active metabolite SN-38 when administered with this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed colorectal cancer
  • Metastatic disease



• Must have been free of disease for at least 1 year if received prior adjuvant fluorouracil



• Epidermal growth factor receptor (EGFR) over-expression by immunochemistry (staining 2+ or 3+ in at least 10% of tumor cells)



• Unidimensionally measurable disease



• No clinically significant ascites or pleural effusion



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior irinotecan

Endocrine therapy

• Not specified

Radiotherapy

• No prior or concurrent radiotherapy for colorectal cancer

Surgery

• Prior surgery for colorectal cancer allowed

Other

• At least 30 days since prior investigational drugs
• No other prior therapy for colorectal cancer
• No prior therapy for metastatic disease
• No prior EGFR-targeting agents
• No concurrent prochlorperazine during days 1-29 of each study course
• No other concurrent EGFR-targeting agents
• No other concurrent investigational drugs
• No other concurrent therapy for colorectal cancer
• No concurrent investigational supportive care therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• AST and ALT no greater than 3 times upper limit of normal

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
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 1 month after study participation
• 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 or laboratory abnormality that would preclude study participation

Expected Enrollment

A total of 84 patients will be accrued for this study.

Outline

This is a multicenter study.

Patients receive monoclonal antibody ABX-EGF IV over 1 hour, irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV over 5 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed within 4 weeks, every 3 months for 1 year, and then every 6 months for 1 year.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Joel Hecht, MD, Principal investigator		Ph: 310-206-4303; 888-798-0719

Registry Information
Official Title		A Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination with Irinotecan, Leucovorin, and 5-Fluorouracil in Patients with Metastatic Colorectal Cancer
Trial Start Date		2002-07-19
Registered in ClinicalTrials.gov		NCT00047151
Date Submitted to PDQ		2002-08-08
Information Last Verified		2004-05-18
NCI Grant/Contract Number		P30-CA16042

Back to Top