An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma
18 Years
N/A
Both
Colorectal Cancer
Trial Information
An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Joel Randolph Hecht, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069368
NCT ID:
NCT00039273
Start Date:
July 2002
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
