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NCT00538031 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study of Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 2
- Study locations
NCT00538031: Completed Phase 2 study of Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, sponsored by City of Hope Medical Center.
NCT00538031 is a Phase 2 study of Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer that has completed, run by City of Hope Medical Center. The registered enrollment target is 52 participants, below the 255-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00538031, a Phase 2 study of Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG celecoxib
Study Locations (2)
California
- City of Hope - Duarte
- City of Hope Medical Group Inc - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2003-12-22 |
| Est. Completion | 2019-09-13 |
| Phase | Phase 2 |
What the finished NCT00538031 record still lists
NCT00538031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 255-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Fallopian Tube Cancer appearing as the primary indexed condition, and to 2 interventions - of which cyclophosphamide is the first listed.
NCT00538031 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00538031 about?
NCT00538031 is a clinical study titled "Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer". 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 cyclop...
What is the current status of trial NCT00538031?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2003-12-22. Estimated completion is 2019-09-13.
What conditions does trial NCT00538031 study?
This clinical trial studies the following conditions: Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Peritoneal Cavity Cancer.
What interventions are being tested in trial NCT00538031?
The interventions under investigation include: cyclophosphamide (DRUG), celecoxib (DRUG).
Who is sponsoring clinical trial NCT00538031?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00538031 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00538031's enrollment target sits among peer trials
52 48th of 85 higher than 38 of 85 other Fallopian Tube Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fallopian Tube Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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