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Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy health trials occur in hundreds of cities throughout 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy. Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Participants oftentimes recieve the most expert healthcare available for their Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "N" Clinical Trials Conditions > Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy  Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: recurrent prostate cancer,adenocarcinoma of the prostate,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
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 nitrocamptothecin in treating men who have stage IV prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: I. Determine the therapeutic efficacy of nitrocamptothecin in patients with metastatic, hormone refractory prostate cancer. II. Determine time to disease progression and duration of response in this patient population as a result of this treatment regimen. III. Determine the safety, tolerance, and toxicity of this treatment regimen in these patients. PROTOCOL OUTLINE: Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study over 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the prostate with clinically progressive stage IVA or IVB disease after at least primary androgen ablation with either orchiectomy or LHRH agonist and only one cytotoxic chemotherapy regimen - Measurable disease with a maximum of 10 measurable lesions OR Nonmeasurable disease; PSA of at least 5.0 ng/mL - Serum testosterone no greater than 50 ng/mL if no prior bilateral orchiectomy --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy and recovered - Chemotherapy: See Disease Characteristics; At least 6 weeks since prior suramin; At least 4 weeks since other prior chemotherapy; No prior therapy with camptothecin or any of its analogues - Endocrine therapy: Prior second line hormonal therapy allowed; At least 4 weeks since prior hormonal therapy; Concurrent treatment with LHRH agonists allowed and required for patients without orchiectomy; No concurrent hormonal therapy except for nondisease related conditions; Concurrent corticosteroids allowed if on stable dose for at least 6 weeks before study; No concurrent dexamethasone as an antiemetic - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No palliative radiotherapy; At least 8 weeks since prior strontium 89 or samarium 153 - Surgery: At least 3 weeks since major surgery and recovered --Patient Characteristics-- - Age: Not specified - Performance status: ECOG 0 or 1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent); No disseminated intravascular coagulation - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST and ALT no greater than 3 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Other: Fertile patients must use effective contraception; No currently active second malignancy other than nonmelanoma skin cancers; No active infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardGelmann, Study Chair, Cancer and Leukemia Group B
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Additional Information:
Study ID Numbers: CDR0000067827; GUMC-00192,CLB-99901
Study Start Date: May 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005820
Other Recurrent Prostate Cancer Studies:
1. Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
2. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
3. Assessing Quality of Life of Patients With Prostate Cancer
4. Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
5. Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
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