Phase 2
N=52
Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube Cancer · Peritoneal Cavity Cancer · Recurrent Ovarian Epithelial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00538031 ↗Enrolled (actual)
52
Serious AEs
23.1%
Results posted
Apr 2023
Primary outcome: Primary: Overall Response — 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cyclophosphamide (Drug); celecoxib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- City of Hope Medical Center
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response |
1; 1 | — |
| PRIMARY Time to Treatment Failure |
1.84; 1.92 | 0.61 |
| PRIMARY Overall Survival |
9.69; 12.55 | 0.95 |
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.
Eligibility Criteria
Inclusion
- Patients with recurrent or residual epithelial ovarian, Fallopian tube, or primary papillary peritoneal cancer, which has been histologically confirmed regardless of prior treatment
- Patients with measurable disease or rising CA-125 to levels at least twice normal (the CA-125 increase must be documented by two independent measurements at least 4 weeks apart)
- Patient must have adequate renal function documented by a creatinine 1.5 x 10^9/L and a platelet count > 100 x 10^9/L
- Patients must have a Karnofsky performance status of 60-100%
- Patient must be capable of understanding the nature of the trial and must give written informed consent
- Patients must have life expectancy of at least three months
- Patients with brain metastases which at the time of study enrollment are controlled and do not require treatment with corticosteroids are eligible
Exclusion
- Patients who have had radiotherapy or chemotherapy within three weeks prior to anticipated first day of dosing (patients must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy
- Patient with unstable or severe intercurrent medical conditions or active, uncontrolled infection
- Patients with history of bleeding peptic ulcer within last 3 months
- Patients undergoing therapy with other investigational agents (patients must have recovered from all acute effects of previously administered investigational agents and sufficient time must have elapsed since last administration to ensure the drug interactions not occur during this study
- Patients who are allergic to sulfa drugs
- Pregnant women will be excluded from this study due to the potential of harm to the fetus
- Patients with clinically significant cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction unstable angina), New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 1 year prior to study entry
- Subjects with hypertension are eligible if their blood pressure as been normal while on a stable dose of medication for at least one year
Data sourced from ClinicalTrials.gov (NCT00538031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.