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Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00313612 |
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: oxaliplatin Drug: topotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer |
Estimated Enrollment: | 52 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients are stratified according to response to prior platinum therapy (resistant vs sensitive).
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable or evaluable disease
Previously treated with a taxane and platinum-based regimen
Meets 1 of the following criteria for response to prior platinum-based therapy:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including the following:
No history of severe allergy to platinum compounds
PRIOR CONCURRENT THERAPY:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
United States, New York | |
New York Weill Cornell Cancer Center at Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
St. Luke's - Roosevelt Hospital Center - St.Luke's Division | Recruiting |
New York, New York, United States, 10025 | |
Contact: Contact Person 212-523-4000 |
Study Chair: | Amy D. Tiersten, MD | Weill Medical College of Cornell University |
Investigator: | Howard S. Hochster, MD | New York University School of Medicine |
Study ID Numbers: | CDR0000467190, NYU-0367, NCI-6317 |
Study First Received: | April 11, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00313612 |
Health Authority: | Unspecified |
recurrent ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Fallopian Tube Neoplasms Recurrence |
Fallopian Tube Diseases Genital Diseases, Female Oxaliplatin Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Topotecan Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Adnexal Diseases |