A Phase 2 interventional study of irinotecan hydrochloride and gefitinib in Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum and Mucinous Adenocarcinoma of the Colon, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-16.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 50 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
At least one unidimensionally measurable lesion
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.
Drug: irinotecan hydrochloride · Drug: gefitinib · Drug: leucovorin calcium · Drug: fluorouracil
Given IV
Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Given orally
Also known as: Iressa, ZD 1839
Given IV
Also known as: CF, CFR, LV
Given IV
Also known as: 5-fluorouracil, 5-Fluracil, 5-FU
Grade 3 or 4 toxicity, graded using the NCI CTC version 2.0
Time frame: Up to 2 years
Response rate
95% confidence interval will be determined.
Time frame: Up to 2 years
This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)