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

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ClinicalTrials.gov Identifier: NCT00316407
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : February 18, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Swedish Medical Center

Brief Summary:
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 or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : August 2005
Primary Completion Date : November 2009
Study Completion Date : November 2009



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


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

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


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
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.

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


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

Responsible Party: Saul Rivkin, M.D., Swedish Cancer Institute
ClinicalTrials.gov Identifier: NCT00316407     History of Changes
Other Study ID Numbers: CRC 0503
First Posted: April 20, 2006    Key Record Dates
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
Neoplasms
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
Paclitaxel
Lapatinib
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors