Overview

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

Status:
Terminated
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborator:
GlaxoSmithKline
Treatments:
Carboplatin
Lapatinib
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