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

NCT ID: NCT00316407

Last Updated: 2011-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lapatinib (GW572016)

1000 mg po qd

Intervention Type DRUG

Carboplatin

AUC 2 weekly x 3 of 4 week cycle

Intervention Type DRUG

Paclitaxel

60 mg/m2 weekly x 3 of 4 week cycle

Intervention Type DRUG

Other Intervention Names

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Tykerb Paraplatin Taxol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Swedish Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Swedish Cancer Institute

Principal Investigators

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Saul Rivkin, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center Cancer Institute

Locations

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University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Swedish Medical Center Cancer Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CRC 0503

Identifier Type: -

Identifier Source: org_study_id

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