Brief Title
Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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
Brief 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.
Detailed Description
OBJECTIVES:
I. 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate
Condition
Fallopian Tube Cancer
Intervention
cyclophosphamide
Study Arms / Comparison Groups
Arm I
Description: Patients receive oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
December 22, 2003
Completion Date
December 22, 2021
Primary Completion Date
December 22, 2021
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
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Vincent Chung, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00538031
Organization ID
03092
Secondary IDs
NCI-2009-01597
Responsible Party
Sponsor
Study Sponsor
City of Hope Medical Center
Study Sponsor
Vincent Chung, Principal Investigator, City of Hope Medical Center
Verification Date
February 2020