Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients

Swedish Medical Center30 enrolled

Overview

The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

lapatinib (GW572016)DRUG

1000 mg po qd

CarboplatinDRUG

AUC 2 weekly x 3 of 4 week cycle

PaclitaxelDRUG

60 mg/m2 weekly x 3 of 4 week cycle

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Swedish Medical Center Cancer Institute

Seattle, Washington, United States

Outcomes

Primary Outcomes

Toxicity

Time frame: 1 year

Secondary Outcomes

Objective response (PR or CR)

Time frame: 1 year

Data from ClinicalTrials.gov

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