A Phase II Trial Of IRESSA (NSC 715055, IND 61187) In Combination With 5-FU/LV/ CPT-11 In Patients With Advanced Or Recurrent Colorectal Cancer

National Cancer Institute (NCI)1 site in 1 country50 target enrollmentOctober 2002

Overview

Brief Summary

Phase II trial to study the effectiveness of combining gefitinib with fluorouracil, leucovorin, and irinotecan in treating patients who have advanced or recurrent colorectal cancer. Biological therapies such as gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with fluorouracil, leucovorin, and irinotecan may kill more tumor cells

Detailed Description

OBJECTIVES: I. Determine the safety of gefitinib, fluorouracil, leucovorin calcium, and irinotecan in patients with advanced or recurrent colorectal cancer. II. Determine the major side effects of this regimen in these patients. III. Determine the response rate, progression-free survival, and overall survival of patients treated with this regimen. IV. Correlate response and other measures of outcome with epidermal growth factor receptor expression and the expression of genes that impact upon pathways of fluoropyrimidine cytotoxicity in patients treated with this regimen. OUTLINE: This is a non-randomized, open-label, multi-center study. Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

November 2004

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Cancer Institute (NCI)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed advanced (stage IV) or recurrent adenocarcinoma of the colon or rectum
•Must have available tissue for immunohistochemical analysis
•At least one unidimensionally measurable lesion
•At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
•Tumor marker (carcinoembryonic antigen) elevation alone is insufficient for study entry
•No known brain metastases
•Performance status - ECOG 0-2
•Granulocyte count at least 1,500/mm\^3
•Platelet count at least 100,000/mm\^3
•Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Exclusion Criteria

Not provided

Arms & Interventions

Treatment (irinotecan, gefitinib, leucovorin, fluorouracil)

Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Intervention: irinotecan hydrochloride

Treatment (irinotecan, gefitinib, leucovorin, fluorouracil)

Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Intervention: gefitinib

Treatment (irinotecan, gefitinib, leucovorin, fluorouracil)

Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Intervention: leucovorin calcium

Treatment (irinotecan, gefitinib, leucovorin, fluorouracil)

Patients receive oral gefitinib daily beginning on day 1, irinotecan IV over 90 minutes on days 1 and 15, and leucovorin calcium IV over 2 hours and fluorouracil IV over 3-5 seconds followed by a 22-hour infusion on days 1, 2, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Intervention: fluorouracil