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Tracking Information | |||||
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First Received Date ICMJE | July 8, 2004 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date ICMJE | January 2005 | ||||
Current Primary Outcome Measures ICMJE |
PSA response rate [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
PSA response rate | ||||
Change History | Complete list of historical versions of study NCT00087165 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Descriptive Information | |||||
Brief Title ICMJE | GTI-2040, Docetaxel, and Prednisone in Treating Patients With Prostate Cancer | ||||
Official Title ICMJE | A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer | ||||
Brief Summary | RATIONALE: GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may help docetaxel kill more tumor cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving GTI-2040 together with docetaxel and prednisone works in treating patients with prostate cancer that has not responded to hormone therapy. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients receive GTI-2040 IV continuously on days 1-14, docetaxel IV on day 3 of course 1 and on day 1 of subsequent courses, and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 3.6-9.5 months. |
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Study Phase | Phase II | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Open Label | ||||
Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00087165 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000372951, PMH-PHL-024, NCI-6102 | ||||
Study Sponsor ICMJE | Princess Margaret Hospital, Canada | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | November 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |