Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients

Swedish Medical Center2 sites in 1 country30 target enrollmentAugust 2005

ConditionsOvarian Epithelial Cancer Stage III Stage IV Ovarian Cancer Stage IV Breast Cancer

Drugslapatinib (GW572016)Carboplatin Paclitaxel

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Ovarian Epithelial Cancer Stage III
Sponsor: Swedish Medical Center
Enrollment: 30
Locations: 2
Primary Endpoint: Toxicity
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2005

End Date

November 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Swedish Medical Center

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.