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

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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 Ovarian Cancer Peritoneal Cavity Cancer	Drug: celecoxib Drug: cyclophosphamide	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Cyclophosphamide Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	54
Study Start Date:	November 2003
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients receive oral cyclophosphamide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.	Drug: cyclophosphamide Given orally
Arm II: Experimental 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.	Drug: celecoxib Given orally Drug: cyclophosphamide Given orally

Detailed Description:

OBJECTIVES:

Primary

To assess the response rate in patients with recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with cyclophosphamide with versus without celecoxib.
To assess the time to disease progression in these patients.
To further describe the toxicities of cyclophosphamide with versus without celecoxib in these patients.

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

DISEASE CHARACTERISTICS:

Histologically confirmed recurrent or persistent ovarian epithelial, fallopian tube, or primary papillary peritoneal cavity cancer
Measurable disease OR rising CA-125 to at least twice the normal level
- The CA-125 increase must be documented by two independent measurements taken at least 4 weeks apart
Controlled brain metastases allowed provided there is no requirement for corticosteroids

PATIENT CHARACTERISTICS:

Inclusion criteria:

Karnofsky performance status 60-100%
Life expectancy ≥ 3 months
ANC > 1,500/mm³
Platelet count > 100,000/mm³
Creatinine < 1.5 mg/dL

Exclusion criteria:

Unstable or severe intercurrent medical conditions or active, uncontrolled infection
History of allergic reactions to nonsteroidal anti-inflammatory or sulfa drugs
Bleeding peptic ulcer within the past 3 months
Any of the following conditions within the past year:
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina)
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Peripheral vascular disease ≥ grade 2

PRIOR CONCURRENT THERAPY:

Recovered from all prior toxicities
More than 3 weeks since prior radiotherapy or chemotherapy
No other concurrent investigational agents or antineoplastic therapy

Contacts and Locations

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

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org
City of Hope Medical Group	Recruiting
Pasadena, California, United States, 91105
Contact: Contact Person 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Vincent Chung, MD

Beckman Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	City of Hope Comprehensive Cancer Center ( Vincent Chung )
Study ID Numbers:	CDR0000567043, CHNMC-03092
Study First Received:	October 1, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00538031
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fallopian tube cancer
peritoneal cavity cancer
recurrent ovarian epithelial cancer

Study placed in the following topic categories:

Ovarian cancer
Celecoxib
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Cyclophosphamide
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms

Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Myeloablative Agonists
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009