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Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00317434
Recruitment Status : Terminated (Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.)
First Posted : April 24, 2006
Last Update Posted : December 15, 2009
Information provided by:
University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE April 20, 2006
First Posted Date  ICMJE April 24, 2006
Last Update Posted Date December 15, 2009
Study Start Date  ICMJE November 2005
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2006)
MTD of Lapatinib measured in cohorts of 3-6 patients each
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2006)
  • Clinical response rate defined by RECIST and CA125 values
  • EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
  • Correlate serum levels of Lapatinib with AE's & efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
Official Title  ICMJE A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer
Brief Summary The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: lapatinib
Study Arms  ICMJE Not Provided
Publications * Kimball KJ, Numnum TM, Kirby TO, Zamboni WC, Estes JM, Barnes MN, Matei DE, Koch KM, Alvarez RD. A phase I study of lapatinib in combination with carboplatin in women with platinum sensitive recurrent ovarian carcinoma. Gynecol Oncol. 2008 Oct;111(1):95-101. doi: 10.1016/j.ygyno.2008.07.001. Epub 2008 Aug 8.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 10, 2009)
Original Enrollment  ICMJE
 (submitted: April 20, 2006)
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologic diagnosis of epithelial ovarian or primary peritoneal cancer
  • Measurable disease or evaluable disease with CA125 >100
  • One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed
  • Recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy
  • 19 years of age or older
  • Life expectancy of greater than 12 weeks
  • Performance status of 0, 1 or 2 (based on GOG Performance Status)
  • Normal bone marrow, renal and hepatic function based upon lab tests
  • Cardiac ejection fraction within institutional normal range
  • Ability to swallow and retain oral medication
  • Ability to understand a written informed consent document

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study
  • Epithelial ovarian tumors of low malignant potential, stromal or germ cell origin
  • Non-measurable or non-evaluable disease
  • Archived tumor tissue not available for assay
  • Patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines
  • Patients with known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
  • Uncontrolled inter-current illness
  • Patients who are pregnant
  • HIV-positive patients receiving combination anti-retroviral therapy
  • Patients with GI tract disease resulting in an inability to take oral medication
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00317434
Other Study ID Numbers  ICMJE UAB 0538 - F051025014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald D. Alvarez, M.D. / Director, Professor - Gynecologic Oncology, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Ronald D. Alvarez, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date December 2009

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