Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026364
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2001-11-09
Brief Title:
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced Locally Recurrent or Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of ZD1839 Iressa In Combination With Irinotecan Leucovorin And 5-Fluorouracil In Previously Untreated Stage IV Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2002-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan leucovorin and fluorouracil in treating patients who have locally advanced locally recurrent or metastatic colorectal cancer Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining ZD 1839 with combination chemotherapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of ZD 1839 in combination with irinotecan leucovorin calcium and fluorouracil in patients with locally advanced locally recurrent or metastatic colorectal cancer
II Determine the dose-limiting toxicity of this regimen in these patients III Determine the pharmacokinetics of this regimen in these patients IV Determine the objective response rate in patients treated with this regimen
V Correlate epidermal growth factor receptor expression with the probability of objective tumor response in these patients
OUTLINE This is a multicenter dose-escalation study of ZD 1839
Patients receive oral ZD 1839 daily Beginning on day 15 patients receive irinotecan IV over 90 minutes leucovorin calcium IV over 15 minutes and fluorouracil IV weekly on weeks 1-2 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ZD 1839 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are accrued to receive treatment at the MTD
Patients are followed for 30 days
I Determine the maximum tolerated dose of ZD 1839 in combination with irinotecan leucovorin calcium and fluorouracil in patients with locally advanced locally recurrent or metastatic colorectal cancer
II Determine the dose-limiting toxicity of this regimen in these patients III Determine the pharmacokinetics of this regimen in these patients IV Determine the objective response rate in patients treated with this regimen
V Correlate epidermal growth factor receptor expression with the probability of objective tumor response in these patients
OUTLINE This is a multicenter dose-escalation study of ZD 1839
Patients receive oral ZD 1839 daily Beginning on day 15 patients receive irinotecan IV over 90 minutes leucovorin calcium IV over 15 minutes and fluorouracil IV weekly on weeks 1-2 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ZD 1839 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are accrued to receive treatment at the MTD
Patients are followed for 30 days
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 |
|---|---|---|---|
| DFCI-01142 | None | None | None |
| NCI-3792 | None | None | None |
| CDR0000069023 | REGISTRY | PDQ Physician Data Query | None |