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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00087165
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : April 28, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: GTI-2040 Drug: docetaxel Drug: prednisone Phase 2

Detailed Description:



  • 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.


  • Determine objective tumor response in patients treated with this regimen.
  • Determine the median time to progression in patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the median duration of PSA response in patients treated with this regimen.
  • Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc, R2 subunit protein, and markers of cellular proliferation and apoptosis with clinical outcomes in patients treated with this regimen.

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer
Actual Study Start Date : January 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. PSA response rate

Secondary Outcome Measures :
  1. Median survival
  2. 1-year survival
  3. Response rate and duration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3


  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • PTT ≤ 1.25 times upper limit of control
  • INR ≤ 1.3


  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 50 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • 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


Biologic therapy

  • No concurrent prophylactic filgrastim (G-CSF) or epoetin alfa


  • 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


  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to > 25% of bone marrow
  • No prior isotope therapy


  • See Disease Characteristics


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00087165

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Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
National Cancer Institute (NCI)
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Principal Investigator: Malcolm J. Moore, MD Princess Margaret Hospital, Canada
Publications of Results:
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Responsible Party: University Health Network, Toronto Identifier: NCT00087165    
Other Study ID Numbers: PMH-PHL-024
CDR0000372951 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Keywords provided by University Health Network, Toronto:
adenocarcinoma of the prostate
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal