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

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lapatinib
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Indiana University School of Medicine

Outcomes

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

Full Information

First Posted
April 20, 2006
Last Updated
December 10, 2009
Sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00317434
Brief Title
Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
Official Title
A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lapatinib
Primary Outcome Measure Information:
Title
MTD of Lapatinib measured in cohorts of 3-6 patients each
Secondary Outcome Measure Information:
Title
Clinical response rate defined by RECIST and CA125 values
Title
EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
Title
Correlate serum levels of Lapatinib with AE's & efficacy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald D. Alvarez, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18692224
Citation
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.
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Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

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