NCT00113373

Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

A Phase II Evaluation of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

Detailed description

OBJECTIVES: Primary I. Determine 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with lapatinib. II. Determine the nature and degree of toxicity of this drug in these patients. Secondary I. Determine the clinical response rate (partial and complete response) in patients treated with this drug. II. Determine the duration of progression-free and overall survival of patients treated with this drug. III. Determine the impact of prognostic variables, including platinum sensitivity, performance status, and cellular histology (clear cell or mucinous type), on patients treated with this drug. IV. Correlate tumor levels of expression of epidermal growth factor receptors (EGFR), phosphorylated EGFR, HER2/neu, and Ki-67, as determined by immunohistochemistry, with clinical response in patients treated with this drug. V. Correlate EGFR mutations in tumor DNA with clinical response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-26 months.

Conditions

• Primary Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	lapatinib ditosylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-05-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2005-06-08
• Last updated: 2019-07-24
• Results posted: 2015-06-11

Locations

1 site across 1 country: United States