Completed

A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2005
See protocol details

Summary

Principal SponsorUniversity Health Network, Toronto
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2005

Actual date on which the first participant was enrolled.

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. Secondary * 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.

Official TitleA Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer
NCT00087165
Principal SponsorUniversity Health Network, Toronto
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, CanadaOpen British Columbia Cancer Agency - Vancouver Cancer Centre in Google Maps
Suspended

Margaret and Charles Juravinski Cancer Centre

Hamilton, Canada
Suspended

London Regional Cancer Program at London Health Sciences Centre

London, Canada
Suspended

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Canada
Completed5 Study Centers