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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00538031
• Date of registration: 01/10/2007
• Primary sponsor: City of Hope Medical Center
• Public title: Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
• Scientific title: Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
• Date of first enrolment: November 2003
• Target sample size: 27
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00538031
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Vincent Chung
• Affiliation: Beckman Research Institute

Key inclusion & exclusion 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

- 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Fallopian Tube Cancer

Peritoneal Cavity Cancer

Recurrent Ovarian Epithelial Cancer

Intervention(s)

Drug: celecoxib

Drug: cyclophosphamide

Primary Outcome(s)

Response rate [Time Frame: 1 year]

Time to disease progression [Time Frame: 1 year]

Toxicity as assessed by NCI CTC v2.0 [Time Frame: 4 weeks after end of treatment]

Secondary ID(s)

03092

CDR0000567043

NCI-2009-01597

Source(s) of Monetary Support

Please refer to primary and secondary sponsors