Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
OBJECTIVES:
Primary
Secondary
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
Recurrent or persistent disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Must have ≥ 1 target lesion to assess response
Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment
Must meet any 1 of the following criteria for platinum-based therapy:
Ineligible for a higher priority GOG clinical trial
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal