Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025142
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2001-10-11
Brief Title:
Gefitinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Colorectal Cancer
Sponsor:
Stanford University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Study of ZD1839 Iressa in Combination With Oxaliplatin 5-Fluorouracil 5-FU and Leucovorin LV in Advanced Solid Malignancies Phase I and Advanced Colorectal Cancers Phase II
Status:
COMPLETED
Status Verified Date:
2005-02
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:
RATIONALE Biological therapies such as gefitinib 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 more than one drug with gefitinib may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of gefitinib and oxaliplatin combined with leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal cancer
PURPOSE Phase II trial to study the effectiveness of gefitinib and oxaliplatin combined with leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of gefitinib and oxaliplatin when combined with fluorouracil and leucovorin calcium in patients with advanced solid tumors Phase I Phase I closed as of 53002
Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients
Determine the dose-limiting toxic effects and other toxic effects of this regimen in these patients
Determine the antitumor response in patients with advanced colorectal adenocarcinoma treated with this regimen Phase II
Determine the overall survival and time to progression in patients with advanced colorectal adenocarcinoma treated with this regimen Phase II
Determine the presence of polymorphisms or other genetic alterations in genes implicated in the action of this regimen and determine their possible relationship with toxic effects of and antitumor response to this regimen in these patients
OUTLINE This is a dose-escalation study of gefitinib and oxaliplatin L-OHP
Phase I closed as of 53002 Patients receive L-OHP IV over 2 hours on day 1 and leucovorin calcium CF IV over 2 hours followed by fluorouracil 5-FU IV bolus and 5-FU IV over 22 hours on days 1 and 2 during all courses Beginning with course 2 patients also receive oral gefitinib daily on days 1-14 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR receive 2 additional courses past CR
Sequential dose escalation of gefitinib is followed by sequential dose escalation of L-OHP Cohorts of 3-6 patients receive escalating doses of gefitinib and L-OHP until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Phase II Patients are stratified according to prior therapy
Stratum A Received no prior therapy or received adjuvant 5-FUCF or adjuvant 5-FUCFirinotecan at least 6 months ago
Stratum B Received prior therapy for metastatic disease or received adjuvant 5-FUCF fewer than 6 months ago or prior irinotecan Patients receive therapy as in phase I closed as of 53002 with L-OHP and gefitinib at the recommended phase II dose
PROJECTED ACCRUAL Approximately 12-15 patients will be accrued for phase I of the study within 4-6 months Phase I closed as of 53002 A total of 30-81 patients 18-46 for stratum A and 12-35 for stratum B will be accrued for phase II of the study within 18 months
Determine the maximum tolerated dose of gefitinib and oxaliplatin when combined with fluorouracil and leucovorin calcium in patients with advanced solid tumors Phase I Phase I closed as of 53002
Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients
Determine the dose-limiting toxic effects and other toxic effects of this regimen in these patients
Determine the antitumor response in patients with advanced colorectal adenocarcinoma treated with this regimen Phase II
Determine the overall survival and time to progression in patients with advanced colorectal adenocarcinoma treated with this regimen Phase II
Determine the presence of polymorphisms or other genetic alterations in genes implicated in the action of this regimen and determine their possible relationship with toxic effects of and antitumor response to this regimen in these patients
OUTLINE This is a dose-escalation study of gefitinib and oxaliplatin L-OHP
Phase I closed as of 53002 Patients receive L-OHP IV over 2 hours on day 1 and leucovorin calcium CF IV over 2 hours followed by fluorouracil 5-FU IV bolus and 5-FU IV over 22 hours on days 1 and 2 during all courses Beginning with course 2 patients also receive oral gefitinib daily on days 1-14 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete response CR receive 2 additional courses past CR
Sequential dose escalation of gefitinib is followed by sequential dose escalation of L-OHP Cohorts of 3-6 patients receive escalating doses of gefitinib and L-OHP until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Phase II Patients are stratified according to prior therapy
Stratum A Received no prior therapy or received adjuvant 5-FUCF or adjuvant 5-FUCFirinotecan at least 6 months ago
Stratum B Received prior therapy for metastatic disease or received adjuvant 5-FUCF fewer than 6 months ago or prior irinotecan Patients receive therapy as in phase I closed as of 53002 with L-OHP and gefitinib at the recommended phase II dose
PROJECTED ACCRUAL Approximately 12-15 patients will be accrued for phase I of the study within 4-6 months Phase I closed as of 53002 A total of 30-81 patients 18-46 for stratum A and 12-35 for stratum B will be accrued for phase II of the study within 18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-4370 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068923 | REGISTRY | None | None |