Ovarian Cancer
Conditions
Keywords
ovarian cancer
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.
Interventions
DRUGlapatinib
Sponsors
GlaxoSmithKline
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD of Lapatinib measured in cohorts of 3-6 patients each | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed