Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI CTRP
REGISTRY · PDQ
interventional
52
1 country
2
Study Start
December 22, 2003
Actual (reported)Primary Completion
April 21, 2011
Actual (reported)Study Completion
September 13, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 13, 2019
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2003
Actual (reported)October 1, 2007
Actual (reported)October 2, 2007
Actual (reported)April 21, 2011
Actual (reported)September 13, 2019
Actual (reported)April 21, 2023
Actual (reported)Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Up to 3 years
Time to Treatment Failure
Estimated using the product-limit method of Kaplan and Meier. Time to treatment failure is defined as the time from initial treatment to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Up to 3 years
Overall Survival
Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment to death from any cause.
Up to 5 years
Patients receive oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive oral cyclophosphamide once daily and oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Given orally
Given orally
City of Hope
Duarte, California, 91010, United States
City of Hope Medical Group Inc
Pasadena, California, 91105, United States
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Vincent Chung
City of Hope Medical Center
52 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2007
First Posted
October 2, 2007
Study Start
December 22, 2003
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 21, 2011
Actual (reported)Study Completion
September 13, 2019
Actual (reported)Last Updated
October 19, 2026
Results First Posted
April 21, 2023
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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