Ovarian Cancer Clinical Trial
Official title:
A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with
persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.
OBJECTIVES:
Primary
- Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free
survival or objective tumor response, in patients with recurrent or persistent ovarian
epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
- Determine the duration of progression-free and overall survival of patients treated with
this regimen.
- Determine the effects of prognostic variables, including platinum sensitivity, initial
performance status, and age, in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days
2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once
daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
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