Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039273
• Other study ID #: CDR0000069368
• Secondary ID: UCLA-0112063IMMU
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2002
• Last updated: January 7, 2013
• Start date: July 2002

Study information

• Verified date: January 2013
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• panitumumab

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.