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

This study has been terminated.
(Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00317434
First received: April 20, 2006
Last updated: December 10, 2009
Last verified: December 2009

April 20, 2006
December 10, 2009
November 2005
March 2007   (final data collection date for primary outcome measure)
MTD of Lapatinib measured in cohorts of 3-6 patients each
Same as current
Complete list of historical versions of study NCT00317434 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: lapatinib
Not Provided
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. Epub 2008 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
April 2007
March 2007   (final data collection date for primary outcome measure)

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
Female
19 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00317434
UAB 0538 - F051025014, 104239
Not Provided
Ronald D. Alvarez, M.D. / Director, Professor - Gynecologic Oncology, University of Alabama at Birmingham
University of Alabama at Birmingham
GlaxoSmithKline
Principal Investigator: Ronald D. Alvarez, MD University of Alabama at Birmingham
University of Alabama at Birmingham
December 2009

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