Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052585
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2003-01-24
Brief Title:
Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of IRESSA NSC 715055 IND 61187 In Combination With 5-FULV CPT-11 In Patients With Advanced Or Recurrent Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000258548 | REGISTRY | PDQ Physician Data Query | None |
| UPCC 06202 | None | None | None |