Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513058
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2007-08-06
Brief Title:
Lapatinib and Vinorelbine in Treating Women With HER2-Overexpressing Locally Advanced or Metastatic Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase I Study Evaluating the Combination of Lapatinib Vinorelbine in Patients With Locally Advanced or Metastatic Breast Cancer Overexpressing HER2
Status:
COMPLETED
Status Verified Date:
2014-01
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:
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 and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the tolerability and feasibility of the lapatinib ditosylate and vinorelbine ditartrate combination by determining the maximum tolerated dose of vinorelbine ditartrate in combination with a biologically active dose of lapatinib ditosylate
Secondary
Determine the maximum administered dose
Investigate the pharmacokinetic interactions related to the combination of vinorelbine ditartrate and lapatinib ditosylate
Determine the toxicity of vinorelbine ditartrate and lapatinib ditosylate
Determine the objective response rate in patients with measurable lesions
Validate the safety and efficacy of the oral vinorelbine ditartrate and lapatinib ditosylate combination according to the vinorelbine ditartrate oralIV dose equivalence
OUTLINE This is a multicenter dose-escalation study
Patients receive oral lapatinib ditosylate on days -7 to 21 for course 1 and on days 1-21 for all other courses Patients also receive vinorelbine ditartrate IV over 15 minutes on days 1 and 8 Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity
Cohorts of 3-9 patients receive escalating doses of lapatinib ditosylate and vinorelbine ditartrate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity during course 1
Once the MTD is determined for oral lapatinib ditosylate and IV vinorelbine ditartrate an additional cohort of 9 patients receive oral vinorelbine ditartrate with oral lapatinib ditosylate as above
Primary
Evaluate the tolerability and feasibility of the lapatinib ditosylate and vinorelbine ditartrate combination by determining the maximum tolerated dose of vinorelbine ditartrate in combination with a biologically active dose of lapatinib ditosylate
Secondary
Determine the maximum administered dose
Investigate the pharmacokinetic interactions related to the combination of vinorelbine ditartrate and lapatinib ditosylate
Determine the toxicity of vinorelbine ditartrate and lapatinib ditosylate
Determine the objective response rate in patients with measurable lesions
Validate the safety and efficacy of the oral vinorelbine ditartrate and lapatinib ditosylate combination according to the vinorelbine ditartrate oralIV dose equivalence
OUTLINE This is a multicenter dose-escalation study
Patients receive oral lapatinib ditosylate on days -7 to 21 for course 1 and on days 1-21 for all other courses Patients also receive vinorelbine ditartrate IV over 15 minutes on days 1 and 8 Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity
Cohorts of 3-9 patients receive escalating doses of lapatinib ditosylate and vinorelbine ditartrate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity during course 1
Once the MTD is determined for oral lapatinib ditosylate and IV vinorelbine ditartrate an additional cohort of 9 patients receive oral vinorelbine ditartrate with oral lapatinib ditosylate as above
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 |
|---|---|---|---|
| 2005-005167-28 | EUDRACT_NUMBER | UNICANCER | None |
| FRE-FNCLCC-GEP-010506 | OTHER | None | None |