Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
OBJECTIVES:
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
patient population.
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
unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
1 year
No
Vincent Chung
Principal Investigator
Beckman Research Institute
United States: Institutional Review Board
03092
NCT00538031
November 2003
Name | Location |
---|---|
City of Hope | Duarte, California 91010 |
City of Hope Medical Group Inc | Pasadena, California 91105 |