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
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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
OBJECTIVES:
- Determine progression-free survival of patients with metastatic colorectal cancer
treated with monoclonal antibody ABX-EGF, irinotecan, leucovorin calcium, and
fluorouracil.
- Determine additional measures of clinical efficacy of this regimen in these patients.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of monoclonal antibody ABX-EGF when administered with
this regimen in these patients.
- Determine the pharmacokinetics of irinotecan and its active metabolite SN-38 when
administered with this regimen in these patients.
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.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study.
Inclusion 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
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
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, 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:
CDR0000257266
NCT ID:
NCT00047151
Start Date:
July 2002
Completion Date:
Related Keywords:
- Colorectal Cancer
- recurrent colon cancer
- stage IV colon cancer
- recurrent rectal cancer
- stage IV rectal cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
