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

Phase 1
19 Years
90 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD of Lapatinib measured in cohorts of 3-6 patients each

Principal Investigator

Ronald D. Alvarez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Food and Drug Administration

Study ID:

UAB 0538 - F051025014



Start Date:

November 2005

Completion Date:

April 2007

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • Ovarian Neoplasms



University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Indiana University School of Medicine Indianapolis, Indiana  46204