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OpenTrials
Completed

NCT Number: NCT00316407

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

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

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Key information

Conditions

Ovarian Epithelial Cancer Stage III Adnexal Diseases Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stage IV Breast Cancer Stage IV Ovarian Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lapatinib (GW572016)

Drug

1000 mg po qd

Other names: Tykerb

carboplatin

Drug

AUC 2 weekly x 3 of 4 week cycle

Other names: Paraplatin

paclitaxel

Drug

60 mg/m2 weekly x 3 of 4 week cycle

Other names: Taxol

Primary outcomes

  1. Toxicity

    Time frame: 1 year

Secondary outcomes

  1. Objective response (PR or CR)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Swedish Medical Center

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2006
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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