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Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical research trials and Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer. Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer  Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primaryperitoneal cancer.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or persistent ovarian epithelial or primary peritoneal cancer - Measurable disease - At least 1 lesion measured in at least 1 dimension - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - At least 1 target lesion - Tumors within a previously irradiated field considered non-target lesions - Paclitaxel resistant - Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR - Progression during prior paclitaxel-based therapy - Platinum resistant or refractory - Treatment-free interval of less than 6 months duration after treatment with prior platinum OR - Progression during prior platinum-based therapy - Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population) PATIENT CHARACTERISTICS: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaurieMarkman, Study Chair, Cleveland Clinic Cancer Center
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3824
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0526
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Women's Cancer Center at Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0084
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, 39534-2576
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-2516
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
Genecologic Oncology Network
Nashville, Tennessee, 37203
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213-3180
United States
Memorial Medical Center
Springfield, Illinois, 62794-9640
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, 37917
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
Additional Information:
Study ID Numbers: CDR0000068875; GOG-0126N
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023907
Other Peritoneal Cavity Cancer Studies:
1. Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
2. Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon alfa in Treating Patients With Recurrent Ovarian Cancer
3. Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
4. Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
5. Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Related Studies:
Other peritoneal cavity cancer Clinical Trials
Other Tennessee Clinical Trials
Other Nashville Clinical Trials
Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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