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Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical research trials and Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer. Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "K" Clinical Trials Conditions > Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer  Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,recurrent ovarian epithelial cancer
Status: Suspended
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 karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment.
Details: OBJECTIVES: - Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer. - Determine the toxicity of this drug in these patients. OUTLINE: This is an open-label study. Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days 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: A total of 19-51 patients will be accrued for this study within 11-22 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial or primary peritoneal cancer - Recurrent or persistent disease - Platinum-resistant disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - At least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target) - Ineligible for a higher priority GOG study or other phase II cytotoxic study for platinum-resistant disease 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) - ALT 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 Cardiovascular - No myocardial infarction within the past 6 months - No cerebrovascular accident within the past 6 months - No transient ischemic attack within the past 6 months - No uncontrolled hypertension - No decompensated or uncontrolled chronic heart failure Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No neuropathy (sensory or motor) grade 2 or greater - No other invasive malignancies within the past 5 years except nonmelanoma skin cancer - No active infection requiring antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 weeks since prior biological or immunological agents Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered - No more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen - No prior karenitecin or camptothecin analogue/derivative Endocrine therapy - At least 1 week since prior hormonal therapy - Concurrent hormone replacement therapy allowed Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 25% of marrow-bearing areas Surgery - Recovered from recent surgery Other - At least 3 weeks since prior therapy directed at this malignancy - No prior anticancer therapy that would preclude study therapy - No concurrent amifostine or other protective reagents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnKavanagh, Study Chair, M.D. Anderson Cancer Center
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Kagoshima City Hospital
Kagoshima City, , 892-8580
Japan
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1740
United States
University of Houston College Of Pharmacy
Houston, Texas, 77030
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Gynecologic Oncology of Middle Tennessee
Nashville, Tennessee, 37203
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-2233
United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, 1450
Australia
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Cooper University Hospital
Camden, New Jersey, 08103-1489
United States
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3864
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6188
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75390-9032
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Additional Information:
Study ID Numbers: CDR0000269898; BIONUM-KTN22307,GOG-0186D
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054119
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
2. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
3. Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
4. Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
5. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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