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About
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.
Full 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.
Enrollment
Sex
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Metastatic carcinoma of presumptive prostate origin
Disease progression after prior hormonal therapy as defined by rising PSA levels
At least 2 consecutive rises in PSA over a reference value, with measurements taken at least 7 days apart
Prior hormonal therapy must include either medical (luteinizing hormone-releasing hormone [LHRH] agonist) OR surgical (orchiectomy) castration
Castrate levels of testosterone < 50 ng/dL
PSA ≥ 20 ng/mL
No known brain metastases
PATIENT CHARACTERISTICS:
Age
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Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent prophylactic antibiotics
No concurrent anticoagulants
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents or therapies
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Data sourced from clinicaltrials.gov
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