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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

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, UCLALos Angeles, California  90095-1781