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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

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: lapatinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2007

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

Secondary Outcome Measures :
  1. Clinical response rate defined by RECIST and CA125 values
  2. EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
  3. Correlate serum levels of Lapatinib with AE's & efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00317434

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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
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Principal Investigator: Ronald D. Alvarez, MD University of Alabama at Birmingham
Publications of Results:
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Responsible Party: Ronald D. Alvarez, M.D. / Director, Professor - Gynecologic Oncology, University of Alabama at Birmingham Identifier: NCT00317434    
Other Study ID Numbers: UAB 0538 - F051025014
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009
Keywords provided by University of Alabama at Birmingham:
ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action