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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 20, 2006
Last Update Posted: February 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Swedish Medical Center
The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

Condition Intervention Phase
Ovarian Epithelial Cancer Stage III Stage IV Ovarian Cancer Stage IV Breast Cancer Drug: lapatinib (GW572016) Drug: Carboplatin Drug: Paclitaxel Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients

Resource links provided by NLM:

Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Objective response (PR or CR) [ Time Frame: 1 year ]

Enrollment: 30
Study Start Date: August 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lapatinib (GW572016)
    1000 mg po qd
    Other Name: Tykerb
    Drug: Carboplatin
    AUC 2 weekly x 3 of 4 week cycle
    Other Name: Paraplatin
    Drug: Paclitaxel
    60 mg/m2 weekly x 3 of 4 week cycle
    Other Name: Taxol
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316407

United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
United States, Washington
Swedish Medical Center Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Principal Investigator: Saul Rivkin, MD Swedish Medical Center Cancer Institute
  More Information

Responsible Party: Saul Rivkin, M.D., Swedish Cancer Institute
ClinicalTrials.gov Identifier: NCT00316407     History of Changes
Other Study ID Numbers: CRC 0503
First Submitted: April 18, 2006
First Posted: April 20, 2006
Last Update Posted: February 18, 2011
Last Verified: March 2010

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors