Status:
COMPLETED
Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients
Lead Sponsor:
Swedish Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Ovarian Epithelial Cancer Stage III
Stage IV Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00316407
Start Date
August 1 2005
End Date
November 1 2009
Last Update
February 18 2011
Active Locations (2)
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1
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
2
Swedish Medical Center Cancer Institute
Seattle, Washington, United States, 98104