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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: lapatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lapatinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTD of Lapatinib measured in cohorts of 3-6 patients each |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer