Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
NCT ID: NCT00023907
Last Updated: 2013-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
INTERVENTIONAL
2001-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
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Detailed Description
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* Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.
* Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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paclitaxel
Eligibility Criteria
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Inclusion Criteria
Age:
* Any age
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No grade 2 or greater neuropathy (sensory and motor)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic or immunologic agents for cancer
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy for cancer and recovered
* Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease
* Initial treatment may include high-dose therapy, consolidation, or extended therapy
* Received at least 1 prior paclitaxel-based chemotherapy regimen
* No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses
* No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
Endocrine therapy:
* At least 1 week since prior hormonal therapy for cancer
* Concurrent hormone replacement therapy allowed
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy for cancer and recovered
* No prior radiotherapy to site(s) of measurable disease
* No prior radiotherapy to more than 25% of marrow-bearing areas
Surgery:
* At least 3 weeks since prior surgery for cancer and recovered
Other:
* At least 3 weeks since other prior therapy for cancer
* No prior anticancer treatment that would preclude study
* No concurrent amifostine or other protective reagents
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Maurie Markman, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Women's Cancer Center at Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States
Genecologic Oncology Network
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Countries
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References
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Gynecologic Oncology Group; Markman M, Blessing J, Rubin SC, Connor J, Hanjani P, Waggoner S. Phase II trial of weekly paclitaxel (80 mg/m2) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jun;101(3):436-40. doi: 10.1016/j.ygyno.2005.10.036. Epub 2005 Dec 2.
Other Identifiers
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GOG-0126N
Identifier Type: -
Identifier Source: secondary_id
CDR0000068875
Identifier Type: -
Identifier Source: org_study_id
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