Status:
TERMINATED
Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
19-90 years
Phase:
PHASE1
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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00317434
Start Date
November 1 2005
End Date
April 1 2007
Last Update
December 15 2009
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
2
Indiana University School of Medicine
Indianapolis, Indiana, United States, 48202