Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
NCT ID: NCT00005820
Last Updated: 2016-07-13
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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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2000-05-31
2006-09-30
Brief Summary
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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.
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Detailed Description
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* Determine the therapeutic efficacy of nitrocamptothecin in patients with metastatic, hormone refractory prostate cancer.
* Determine time to disease progression and duration of response in this patient population as a result of this treatment regimen.
* Determine the safety, tolerance, and toxicity of this treatment regimen in these patients.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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nitrocamptothecin
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.
nitrocamptothecin
Interventions
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nitrocamptothecin
Eligibility Criteria
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Inclusion Criteria
* 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
* Serum testosterone no greater than 50 ng/mL if no prior bilateral orchiectomy
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
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
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Edward P. Gelmann, MD
Role: STUDY_CHAIR
Lombardi Comprehensive Cancer Center
Locations
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Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
University of California San Diego Cancer Center
La Jolla, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus
Togus, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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Amin A, Halabi S, Gelmann EP, Stadler W, Vogelzang N, Small E. 9-Nitrocamptothecin as second line chemotherapy for men with progressive, metastatic, hormone refractory prostate cancer: Results of the CALGB 99901. Urol Oncol. 2004 Sep-Oct;22(5):398-403. doi: 10.1016/j.urolonc.2004.05.002.
Other Identifiers
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CLB-99901
Identifier Type: -
Identifier Source: secondary_id
GUMC-00192
Identifier Type: -
Identifier Source: secondary_id
CDR0000067827
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-99901
Identifier Type: -
Identifier Source: org_study_id
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