A Phase II Evaluation of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989, IND # 70,252) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
OBJECTIVES: Primary I. Determine 6-month progression-free survival of patients with
persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with
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
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
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
An analysis of any potential treatment effect on PFS or overall survival may be conducted against historical controls using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.
Gynecologic Oncology Group
United States: Food and Drug Administration
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|