Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389922
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2006-10-18
Brief Title:
Lapatinib and Vinorelbine in Treating Patients With Advanced Solid Tumors
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Phase I Study of Two Different Schedules of Lapatinib GW572016 in Combination With Vinorelbine in Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-04
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 Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as vinorelbine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving lapatinib together with vinorelbine may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib when given together with vinorelbine in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib when given together with vinorelbine in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the safety and feasibility of 2 different schedules of lapatinib ditosylate when administered with vinorelbine ditartrate in patients with advanced solid tumors
Secondary
Determine the maximum tolerated dose MTD of each of these regimens in these patients
Determine preliminarily the efficacy of these regimens in these patients
Examine tissue and blood specimens from these patients to investigate potential predictors of response
Determine the pharmacokinetics of lapatinib ditosylate and vinorelbine ditartrate in patients treated at the MTD
OUTLINE This is a phase I study comprising 2 separate sequential dose-escalation studies of lapatinib ditosylate Patients are assigned to 1 of 2 treatment groups
Group A daily dosing Patients receive oral lapatinib ditosylate once daily on days 1-28 and vinorelbine ditartrate IV on days 1 8 and 15
Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate 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 during course 1 At least 6 patients are treated at the MTD Once the MTD of lapatinib has been determined patients may be accrued to group B or to a separate pharmacokinetics cohort in group A
Pharmacokinetics PK cohort Patients in the PK cohort receive vinorelbine ditartrate IV as in group A and oral lapatinib ditosylate once daily at the MTD on days 3-28 course 1 only and on days 1-28 in all subsequent courses Patients undergo PK sampling during course 1
NOTE Accrual to group B and to the PK cohort of group A may occur simultaneously
Group B intermittent dosing Patients receive oral lapatinib ditosylate once daily at the MTD on days 2-5 9-12 and 16-25 and vinorelbine ditartrate IV on days 1 8 and 15
In both groups and in the PK cohort treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients who have completed 6 courses of combined therapy may receive additional courses with lapatinib ditosylate alone
Patients undergo blood collection and buccal brushings periodically for pharmacokinetic and biomarker correlative studies Archival tumor tissue is also evaluated for biomarkers including epidermal growth factor receptor EGFR and HER-2neu expression levels EGFR polymorphisms and gene mutations including RAS levels of cellular proliferation and apoptosis and RAS mutations by immunohistochemistry mutation analysis TUNEL assay and polymerase chain reaction
After completion of study treatment patients are followed for 30 days
PROJECTED ACCRUAL A total of 66 patients will be accrued for this study
Primary
Determine the safety and feasibility of 2 different schedules of lapatinib ditosylate when administered with vinorelbine ditartrate in patients with advanced solid tumors
Secondary
Determine the maximum tolerated dose MTD of each of these regimens in these patients
Determine preliminarily the efficacy of these regimens in these patients
Examine tissue and blood specimens from these patients to investigate potential predictors of response
Determine the pharmacokinetics of lapatinib ditosylate and vinorelbine ditartrate in patients treated at the MTD
OUTLINE This is a phase I study comprising 2 separate sequential dose-escalation studies of lapatinib ditosylate Patients are assigned to 1 of 2 treatment groups
Group A daily dosing Patients receive oral lapatinib ditosylate once daily on days 1-28 and vinorelbine ditartrate IV on days 1 8 and 15
Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate 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 during course 1 At least 6 patients are treated at the MTD Once the MTD of lapatinib has been determined patients may be accrued to group B or to a separate pharmacokinetics cohort in group A
Pharmacokinetics PK cohort Patients in the PK cohort receive vinorelbine ditartrate IV as in group A and oral lapatinib ditosylate once daily at the MTD on days 3-28 course 1 only and on days 1-28 in all subsequent courses Patients undergo PK sampling during course 1
NOTE Accrual to group B and to the PK cohort of group A may occur simultaneously
Group B intermittent dosing Patients receive oral lapatinib ditosylate once daily at the MTD on days 2-5 9-12 and 16-25 and vinorelbine ditartrate IV on days 1 8 and 15
In both groups and in the PK cohort treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients who have completed 6 courses of combined therapy may receive additional courses with lapatinib ditosylate alone
Patients undergo blood collection and buccal brushings periodically for pharmacokinetic and biomarker correlative studies Archival tumor tissue is also evaluated for biomarkers including epidermal growth factor receptor EGFR and HER-2neu expression levels EGFR polymorphisms and gene mutations including RAS levels of cellular proliferation and apoptosis and RAS mutations by immunohistochemistry mutation analysis TUNEL assay and polymerase chain reaction
After completion of study treatment patients are followed for 30 days
PROJECTED ACCRUAL A total of 66 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA093373 | NIH | None | None |
| UCDCC-171 | OTHER | None | None |
| UCDCC-200513681-1 | OTHER | None | None |
| GSK-104241 | OTHER | GlaxoSmithKline | httpsreporternihgovquickSearchP30CA093373 |