Back to resultsLapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients
Primary Purpose
Ovarian Epithelial Cancer Stage III, Stage IV Ovarian Cancer, Stage IV Breast Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lapatinib (GW572016)
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Epithelial Cancer Stage III
Eligibility Criteria
Inclusion Criteria: Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients. Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease. Ability to swallow and retain oral medications. Measurable disease Exclusion Criteria: Treatment with previous weekly carboplatin and paclitaxel. No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab. No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.
Sites / Locations
- University of New Mexico Cancer Center
- Swedish Medical Center Cancer Institute
Outcomes
Primary Outcome Measures
Toxicity
Secondary Outcome Measures
Objective response (PR or CR)
Full Information
NCT ID
NCT00316407
First Posted
April 18, 2006
Last Updated
February 16, 2011
Sponsor
Swedish Medical Center
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00316407
Brief Title
Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients
Official Title
Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Swedish Medical Center
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.
Detailed Description
The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Epithelial Cancer Stage III, Stage IV Ovarian Cancer, Stage IV Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
lapatinib (GW572016)
Other Intervention Name(s)
Tykerb
Intervention Description
1000 mg po qd
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
AUC 2 weekly x 3 of 4 week cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
60 mg/m2 weekly x 3 of 4 week cycle
Primary Outcome Measure Information:
Title
Toxicity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective response (PR or CR)
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.
Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.
Ability to swallow and retain oral medications.
Measurable disease
Exclusion Criteria:
Treatment with previous weekly carboplatin and paclitaxel.
No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.
No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saul Rivkin, MD
Organizational Affiliation
Swedish Medical Center Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Swedish Medical Center Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients
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