Fallopian Tube CancerPhase 2NCT00538031
Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study testing cyclophosphamide and celecoxib in people with Fallopian Tube Cancer and Peritoneal Cavity Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
- What is being tested?
- cyclophosphamide and celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Dec 2003to 13 Sep 2019
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients must have adequate bone marrow function as evidenced by an absolute neutrophil count of > 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope
Duarte, California, 91010
City of Hope Medical Group Inc
Pasadena, California, 91105
About this study
Official title: Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, 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 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.
Read the detailed description
OBJECTIVES:
- 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.
- Being tested
- cyclophosphamide, celecoxib
- Medical subject headings
- Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given orally
celecoxibDrug
Also called Celebrex, SC-58635, YM 177
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: cyclophosphamide |
| Arm II | Experimental | 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. Receives: Drug: cyclophosphamide; Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study start22 Dec 2003
- Primary completion21 Apr 2011
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Chung, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538031
- Sponsor's protocol ID
- 03092
- Other IDs
- NCI-2009-01597, CDR0000567043
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2007
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37185961