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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00087165
First received: July 8, 2004
Last updated: August 18, 2011
Last verified: November 2005
  Purpose

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 Intervention Phase
Prostate Cancer
Biological: GTI-2040
Drug: docetaxel
Drug: prednisone
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PSA response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median survival [ Designated as safety issue: No ]
  • 1-year survival [ Designated as safety issue: No ]
  • Response rate and duration [ Designated as safety issue: No ]

Study Start Date: January 2005
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087165

Locations
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
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Malcolm J. Moore, MD Princess Margaret Hospital, Canada
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00087165     History of Changes
Other Study ID Numbers: CDR0000372951, PMH-PHL-024, NCI-6102
Study First Received: July 8, 2004
Last Updated: August 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Prednisone
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014