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| Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00057863 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in treating patients who have locally recurrent or metastatic cervical cancer.
| Condition | Intervention | Phase |
|
Cervical Cancer |
Drug: oxaliplatin Drug: paclitaxel |
Phase II |
| MedlinePlus related topics: | Cancer Cervical Cancer |
| Drug Information available for: | Paclitaxel Oxaliplatin |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Oxaliplatin In Combination With Paclitaxel In Patients With Locally Recurrent Or Metastatic Cervical Cancer |
| Estimated Enrollment: | 46 |
| Study Start Date: | February 2003 |
| Estimated Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed ever 3 months.
PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-23 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cervical cancer of 1 of the following subtypes:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Connecticut | |||||
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |||||
| Farmington, Connecticut, United States, 06360-2875 | |||||
| United States, New York | |||||
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |||||
| Bronx, New York, United States, 10461 | |||||
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |||||
| New York, New York, United States, 10032 | |||||
| Mount Sinai School of Medicine | |||||
| New York, New York, United States, 10029 | |||||
| New York Weill Cornell Cancer Center at Cornell University | |||||
| New York, New York, United States, 10021 | |||||
| NYU Cancer Institute at New York University Medical Center | |||||
| New York, New York, United States, 10016 | |||||
| Australia, New South Wales | |||||
| Sydney Cancer Centre at Royal Prince Alfred Hospital | |||||
| Sydney, New South Wales, Australia, 2050 | |||||
| Albert Einstein College of Medicine of Yeshiva University |
| National Cancer Institute (NCI) |
| Study Chair: | Dennis Y. Kuo, MD | Albert Einstein College of Medicine of Yeshiva University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000277249, AECM-0902492, NCI-5840 |
| First Received: | April 7, 2003 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00057863 |
| Health Authority: | United States: Food and Drug Administration |
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