Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042809
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2002-08-05
Brief Title:
Erlotinib Trastuzumab and Paclitaxel in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study To Determine The Safety Tolerance And Preliminary Antineoplastic Activity Of Combined EGFR erbB1 And HER2 erbB2 Blockade With OSI-774 And Trastuzumab In Combination With Weekly Paclitaxel
Status:
COMPLETED
Status Verified Date:
2013-01
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 and trastuzumab with paclitaxel in treating patients who have advanced solid tumors Biological therapies such as erlotinib may interfere with the growth of the tumor cells and slow the growth of the tumor Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining erlotinib and trastuzumab with paclitaxel may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the safety quantitative and qualitative toxic effects maximum tolerated dose and dose-limiting toxic effects of erlotinib when combined with paclitaxel and trastuzumab Herceptin in patients with advanced solid tumors
II Determine the relevant pharmacokinetic interactions between these agents in these patients
III Determine preliminarily the antitumor activity of this regimen in these patients
OUTLINE This is an open-label non-randomized multicenter dose-escalation study of erlotinib
Intermittent schedule Patients receive paclitaxel IV over 1 hour followed 30 minutes later by trastuzumab Herceptin IV over 30 minutes on days 1 8 and 15 of each course Patients also receive oral erlotinib once daily on days 3-28 of course 1 and on days 1-28 of subsequent courses Courses repeat every 28 days 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
Continuous schedule Once the MTD is determined using the intermittent schedule an additional 12 patients are accrued to study the tolerability of a continuous schedule comprising paclitaxel and trastuzumab as above on days 1 8 15 and 22 and oral erlotinib once daily on days 3-28 during course 1 and on days 1-28 of subsequent courses using the same dose-escalation scheme as above Courses repeat as above
Patients are followed every 30 days
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study within 10-133 months
I Determine the safety quantitative and qualitative toxic effects maximum tolerated dose and dose-limiting toxic effects of erlotinib when combined with paclitaxel and trastuzumab Herceptin in patients with advanced solid tumors
II Determine the relevant pharmacokinetic interactions between these agents in these patients
III Determine preliminarily the antitumor activity of this regimen in these patients
OUTLINE This is an open-label non-randomized multicenter dose-escalation study of erlotinib
Intermittent schedule Patients receive paclitaxel IV over 1 hour followed 30 minutes later by trastuzumab Herceptin IV over 30 minutes on days 1 8 and 15 of each course Patients also receive oral erlotinib once daily on days 3-28 of course 1 and on days 1-28 of subsequent courses Courses repeat every 28 days 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
Continuous schedule Once the MTD is determined using the intermittent schedule an additional 12 patients are accrued to study the tolerability of a continuous schedule comprising paclitaxel and trastuzumab as above on days 1 8 15 and 22 and oral erlotinib once daily on days 3-28 during course 1 and on days 1-28 of subsequent courses using the same dose-escalation scheme as above Courses repeat as above
Patients are followed every 30 days
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study within 10-133 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 |
|---|---|---|---|
| IDD 01-35 | None | None | None |
| U01CA069853 | NIH | None | None |
| CDR0000069472 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA069853 |