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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00316407
First received: April 18, 2006
Last updated: February 16, 2011
Last verified: March 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316407

Locations
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
GlaxoSmithKline
Investigators
Principal Investigator: Saul Rivkin, MD Swedish Medical Center Cancer Institute
  More Information

No publications provided

Responsible Party: Saul Rivkin, M.D., Swedish Cancer Institute
ClinicalTrials.gov 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
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Neoplasms by Histologic Type
Lapatinib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013