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Status:

COMPLETED

GTI-2040, Docetaxel, and Prednisone in Treating Patients With Prostate Cancer

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Prostate Cancer

Eligibility:

MALE

18-120 years

Phase:

PHASE2

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 fro...

Detailed Description

OBJECTIVES: Primary * Determine the efficacy of GTI-2040, docetaxel, and prednisone, in terms of prostate-specific antigen (PSA) response rate, in patients with hormone-refractory prostate cancer. ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of 1 of the following:
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic carcinoma of presumptive prostate origin
  • Bony metastases AND a serum prostate-specific antigen (PSA) level \> 20 ng/mL
  • 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
  • Patients who received prior LHRH agonist must continue or re-start such therapy
  • Castrate levels of testosterone \< 50 ng/dL
  • PSA ≥ 20 ng/mL
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • More than 3 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • WBC ≥ 3,000/mm\^3
  • Hepatic
  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • PTT ≤ 1.25 times upper limit of control
  • INR ≤ 1.3
  • Renal
  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 50 mL/min
  • Cardiovascular
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Other
  • Fertile patients must use effective contraception
  • No symptomatic peripheral neuropathy ≥ grade 2
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to GTI-2040 or other study agents
  • No concurrent uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent prophylactic filgrastim (G-CSF) or epoetin alfa
  • Chemotherapy
  • No prior chemotherapy except monotherapy with oral estramustine
  • At least 4 weeks since prior estramustine and recovered
  • Endocrine therapy
  • See Disease Characteristics
  • At least 6 weeks since prior bicalutamide\*
  • At least 4 weeks since prior flutamide, nilutamide, or cyproterone\*
  • Concurrent steroids allowed NOTE: \*Patients must have evidence of disease progression despite cessation of antiandrogen therapy
  • Radiotherapy
  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to \> 25% of bone marrow
  • No prior isotope therapy
  • Surgery
  • See Disease Characteristics
  • Other
  • No concurrent prophylactic antibiotics
  • No concurrent anticoagulants
  • Concurrent low-dose warfarin for prophylaxis of central line thrombosis allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents or therapies

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2006

    Estimated Enrollment :

    22 Patients enrolled

    Trial Details

    Trial ID

    NCT00087165

    Start Date

    January 1 2005

    End Date

    December 1 2006

    Last Update

    April 28 2021

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    2

    Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, Canada, L8V 5C2

    3

    London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, Canada, N6A 4L6

    4

    Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, Canada, K1H 8L6