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
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: lapatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • MTD of Lapatinib measured in cohorts of 3-6 patients each

Secondary Outcome Measures:
  • 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

Enrollment: 12
Study Start Date: November 2005
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317434

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 48202
Sponsors and Collaborators
University of Alabama at Birmingham
GlaxoSmithKline
Investigators
Principal Investigator: Ronald D. Alvarez, MD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Ronald D. Alvarez, M.D. / Director, Professor - Gynecologic Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00317434     History of Changes
Other Study ID Numbers: UAB 0538 - F051025014, 104239
Study First Received: April 20, 2006
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Lapatinib
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014