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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

April 18, 2006
February 16, 2011
August 2005
November 2009   (final data collection date for primary outcome measure)
Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00316407 on ClinicalTrials.gov Archive Site
Objective response (PR or CR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients
Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients

The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Epithelial Cancer Stage III
  • Stage IV Ovarian Cancer
  • Stage IV Breast Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316407
CRC 0503
No
Saul Rivkin, M.D., Swedish Cancer Institute
Swedish Medical Center
GlaxoSmithKline
Principal Investigator: Saul Rivkin, MD Swedish Medical Center Cancer Institute
Swedish Medical Center
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP