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

Sponsor:	City of Hope Medical Center
Information provided by (Responsible Party):	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00538031

Purpose

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.

Condition	Intervention	Phase
Fallopian Tube Cancer Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer	Drug: cyclophosphamide Drug: celecoxib	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cyclophosphamide Celecoxib

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Time to disease progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Toxicity as assessed by NCI CTC v2.0 [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	27
Study Start Date:	November 2003
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm I Patients receive oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.	Drug: cyclophosphamide Given orally Other Names: CPM CTX Cytoxan Endoxan Endoxana Enduxan
Experimental: Arm II 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.	Drug: cyclophosphamide Given orally Other Names: CPM CTX Cytoxan Endoxan Endoxana Enduxan Drug: celecoxib Given orally Other Names: Celebrex SC-58635 YM 177

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538031

Locations

United States, California
City of Hope
Duarte, California, United States, 91010
City of Hope Medical Group Inc
Pasadena, California, United States, 91105

Sponsors and Collaborators

City of Hope Medical Center

Investigators

Principal Investigator:

Vincent Chung

Beckman Research Institute

More Information

No publications provided

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00538031 History of Changes
Other Study ID Numbers:	03092, NCI-2009-01597, CDR0000567043
Study First Received:	October 1, 2007
Last Updated:	September 20, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female

Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Cyclophosphamide
Celecoxib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on February 09, 2012