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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00538031 |
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 |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: celecoxib Drug: cyclophosphamide |
Phase II |
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 |
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 |
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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.
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Drug: cyclophosphamide
Given orally
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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.
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Drug: celecoxib
Given orally
Drug: cyclophosphamide
Given orally
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OBJECTIVES:
Primary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease OR rising CA-125 to at least twice the normal level
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Any of the following conditions within the past year:
PRIOR CONCURRENT THERAPY:
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 626-396-2900 |
Study Chair: | Vincent Chung, MD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( Vincent Chung ) |
Study ID Numbers: | CDR0000567043, CHNMC-03092 |
Study First Received: | October 1, 2007 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00538031 History of Changes |
Health Authority: | Unspecified |
fallopian tube cancer peritoneal cavity cancer recurrent ovarian epithelial cancer |
Anti-Inflammatory Agents Fallopian Tube Cancer Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Anti-Inflammatory Agents, Non-Steroidal Analgesics Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms |
Digestive System Neoplasms Celecoxib Cyclooxygenase Inhibitors Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Ovarian Epithelial Cancer Immunosuppressive Agents Recurrence Fallopian Tube Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Antineoplastic Agents, Alkylating |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Genital Diseases, Female Neoplasms by Site Sensory System Agents Therapeutic Uses Peritoneal Diseases Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Celecoxib Cyclooxygenase Inhibitors Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Abdominal Neoplasms Immunosuppressive Agents Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases |