Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
I. To assess the response rates in patients with recurrent or persistent epithelial ovarian,
fallopian tube or primary peritoneal cancer who are treated with oral cyclophosphamide alone
or oral cyclophosphamide with celecoxib.
II. To assess the time to disease progression in this group of patients. III. To further
describe the toxicities of oral cyclophosphamide with or without celecoxib in the above
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral cyclophosphamide once daily on days 1-28. Courses repeat every
4 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oral cyclophosphamide once daily and oral celecoxib twice daily on
days 1-28. Courses repeat every 4 weeks in the absence of disease progression or
After completion of study treatment, patients are followed periodically.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Beckman Research Institute
United States: Institutional Review Board
|City of Hope||Duarte, California 91010|
|City of Hope Medical Group Inc||Pasadena, California 91105|