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Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

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Trial Information

Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Vincent Chung

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

03092

NCT ID:

NCT00538031

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

City of HopeDuarte, California  91010
City of Hope Medical Group IncPasadena, California  91105