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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00317434
• Other study ID #: UAB 0538 - F051025014
• Secondary ID: 104239
• Status: Terminated
• Phase: Phase 1
• First received: April 20, 2006
• Last updated: December 10, 2009
• Start date: November 2005
• Est. completion date: April 2007

Study information

• Verified date: December 2009
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• lapatinib

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kimball KJ, Numnum TM, Kirby TO, Zamboni WC, Estes JM, Barnes MN, Matei DE, Koch KM, Alvarez RD. A phase I study of lapatinib in combination with carboplatin in women with platinum sensitive recurrent ovarian carcinoma. Gynecol Oncol. 2008 Oct;111(1):95-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD of Lapatinib measured in cohorts of 3-6 patients each
Secondary	Clinical response rate defined by RECIST and CA125 values
Secondary	EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
Secondary	Correlate serum levels of Lapatinib with AE's & efficacy