drugset / Trial / NCT00538031

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

NCT00538031 ↗

Phase 2 Completed 52 enrolled City of Hope Medical Center
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2003-12-22
Primary completion
2011-04-21
Completion
2019-09-13

Outcome

Missed primary endpoint

registry analysis (other test); Arm I (Cyclophosphamide Alone) vs Arm II (Cyclophosphamide + Celecoxib); p = 0.61; Log Rank NCT00538031 ↗

registry analysis (other test); Arm I (Cyclophosphamide Alone) vs Arm II (Cyclophosphamide + Celecoxib); p = 0.95; Log Rank NCT00538031 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Celecoxib Other / unclassified — Oral
Subject Cyclophosphamide Other / unclassified — Oral