Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045201
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2002-09-06
Brief Title:
Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of OSI-774 and CPT-11 in Patients With Advanced Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 combining erlotinib hydrochloride with irinotecan hydrochloride in treating patients who have advanced solid tumors Erlotinib hydrochloride 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 erlotinib hydrochloride and chemotherapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose MTD of erlotinib erlotinib hydrochloride and irinotecan irinotecan hydrochloride in relation to presence or absence of UGT1A128 polymorphism in patients with advanced solid tumors that overexpress epidermal growth factor receptor
II Determine the dose-limiting toxicity of these regimens in these patients III Determine whether erlotinib alters the disposition of irinotecan using a previously described limited sampling model
IV Determine factors that influence the disposition of these drugs including genetic variation in UGT1A1 and BCRP in patients treated with these regimens
V Determine factors that influence the disposition of these drugs in terms of tumor BCRP-expression in tumor samples from patients treated with these drugs at the MTD
VI Evaluate the effect of this regimen on epidermal growth factor receptor phosphorylation in these patients
VII Assess preliminarily any antitumor activity in patients treated with these regimens
VIII Correlate preliminarily EGFR phosphorylation andor BCRP -expression with response in tumor samples from these patients
OUTLINE This is a dose-escalation study Patients are stratified according to UGTA1A genotype all patients regardless of genotype closed to accrual as of 91504 vs UGT1A1 66 genotype vs UGTA1A 67 or 77 genotype
Patients receive oral erlotinib hydrochloride daily on days -6 to -1 Patients then receive irinotecan hydrochloride intravenously IV over 90 minutes on day 1 and oral erlotinib once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of erlotinib hydrochloride and irinotecan hydrochloride until the 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 Additional patients are treated at the MTD
Patients are followed for 3 months
I Determine the maximum tolerated dose MTD of erlotinib erlotinib hydrochloride and irinotecan irinotecan hydrochloride in relation to presence or absence of UGT1A128 polymorphism in patients with advanced solid tumors that overexpress epidermal growth factor receptor
II Determine the dose-limiting toxicity of these regimens in these patients III Determine whether erlotinib alters the disposition of irinotecan using a previously described limited sampling model
IV Determine factors that influence the disposition of these drugs including genetic variation in UGT1A1 and BCRP in patients treated with these regimens
V Determine factors that influence the disposition of these drugs in terms of tumor BCRP-expression in tumor samples from patients treated with these drugs at the MTD
VI Evaluate the effect of this regimen on epidermal growth factor receptor phosphorylation in these patients
VII Assess preliminarily any antitumor activity in patients treated with these regimens
VIII Correlate preliminarily EGFR phosphorylation andor BCRP -expression with response in tumor samples from these patients
OUTLINE This is a dose-escalation study Patients are stratified according to UGTA1A genotype all patients regardless of genotype closed to accrual as of 91504 vs UGT1A1 66 genotype vs UGTA1A 67 or 77 genotype
Patients receive oral erlotinib hydrochloride daily on days -6 to -1 Patients then receive irinotecan hydrochloride intravenously IV over 90 minutes on day 1 and oral erlotinib once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of erlotinib hydrochloride and irinotecan hydrochloride until the 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 Additional patients are treated at the MTD
Patients are followed for 3 months
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 |
|---|---|---|---|
| NCI-2009-00015 | REGISTRY | None | None |
| CDR0000256910 | None | None | None |
| 594-02 01 | None | None | None |
| NCI-5351 | None | None | None |
| MAYO-MC0112 | None | None | None |
| MC0112 | OTHER | None | None |
| 5351 | OTHER | None | None |
| P30CA015083 | NIH | None | None |
| U01CA069912 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069912 |