Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049101
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2002-11-12
Brief Title:
Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study Of OSI-774 In Combination With Oxaliplatin And 5-Fluourouracil In Patients With Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2004-04
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Combining erlotinib with combination chemotherapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining erlotinib with oxaliplatin leucovorin and fluorouracil in treating patients who have metastatic colorectal cancer
PURPOSE Phase III trial to study the effectiveness of combining erlotinib with oxaliplatin leucovorin and fluorouracil in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of erlotinib when administered with oxaliplatin leucovorin calcium and fluorouracil in patients with metastatic colorectal cancer
Determine the pharmacokinetics of this regimen in these patients
Determine any antitumor activity of this regimen in these patients
Determine the time to progression in patients treated with this regimen
Determine the objective response rate and response duration in patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a dose-escalation study of erlotinib
Phase I During the first week of the first course only patients receive oral erlotinib daily alone Patients then begin the regular schedule comprising oral erlotinib daily oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 Treatment repeats every 2 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive erlotinib at the MTD plus oxaliplatin leucovorin calcium and fluorouracil as in phase I Erlotinib may be administered alone if toxicity is caused by oxaliplatin leucovorin calcium and fluorouracil
Patients are followed for at least 6 months or until disease progression
PROJECTED ACCRUAL A total of 4-18 patients will be accrued for phase I of this study within 1-4 months A total of 50 patients will be accrued for phase II of this study within 10 months
Determine the maximum tolerated dose of erlotinib when administered with oxaliplatin leucovorin calcium and fluorouracil in patients with metastatic colorectal cancer
Determine the pharmacokinetics of this regimen in these patients
Determine any antitumor activity of this regimen in these patients
Determine the time to progression in patients treated with this regimen
Determine the objective response rate and response duration in patients treated with this regimen
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a dose-escalation study of erlotinib
Phase I During the first week of the first course only patients receive oral erlotinib daily alone Patients then begin the regular schedule comprising oral erlotinib daily oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 Treatment repeats every 2 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive erlotinib at the MTD plus oxaliplatin leucovorin calcium and fluorouracil as in phase I Erlotinib may be administered alone if toxicity is caused by oxaliplatin leucovorin calcium and fluorouracil
Patients are followed for at least 6 months or until disease progression
PROJECTED ACCRUAL A total of 4-18 patients will be accrued for phase I of this study within 1-4 months A total of 50 patients will be accrued for phase II of this study within 10 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-5371 | None | None | None |
| MSKCC-02039 | None | None | None |