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

This study has been completed.
Information provided by:
Swedish Medical Center Identifier:
First received: April 18, 2006
Last updated: February 16, 2011
Last verified: March 2010
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: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response (PR or CR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

Ages Eligible for Study:   18 Years and older
Genders 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
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Please refer to this study by its identifier: 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 Identifier: NCT00316407     History of Changes
Other Study ID Numbers: CRC 0503 
Study First Received: April 18, 2006
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms
Albumin-Bound Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Tubulin Modulators processed this record on May 26, 2016