NCT00538031

Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with celecoxib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide together with celecoxib works compared to cyclophosphamide alone in treating patients with recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Detailed description

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.

Conditions

• Fallopian Tube Cancer
• Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	cyclophosphamide	Given orally
DRUG	celecoxib	Given orally

Timeline

• Start date: 2003-12-22
• Primary completion: 2011-04-21
• Completion: 2019-09-13
• First posted: 2007-10-02
• Last updated: 2023-04-21
• Results posted: 2023-04-21

Locations

2 sites across 1 country: United States