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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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:
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on March 03, 2015