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

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

Start Date

December 22, 2003

Completion Date

December 2020

Primary Completion Date

December 2020

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

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