Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Prostate Cancer

Eligibility:

MALE

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-01...

Detailed Description

OBJECTIVES: Primary * Determine the efficacy, in terms of prostate-specific antigen response, of docetaxel and prednisone with or without OGX-011 in patients with hormone-refractory locally recurren...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic or locally recurrent disease
  • Not curable with standard therapy
  • Systemic chemotherapy is indicated, due to disease progression while receiving androgen-ablative therapy (i.e., hormone-refractory disease)
  • Disease progression is defined as development of new metastatic lesions OR ≥ 2 consecutive rises in prostate-specific antigen (PSA) over a reference value
  • Androgen ablative therapy must have included either medical or surgical castration
  • Castrate level of testosterone (≤ 1.7 nmol/L) required if treated with medical androgen ablation
  • Patients with documented disease progression while on peripheral antiandrogens must also have documented PSA progression after stopping antiandrogens
  • PSA ≥ 5 ng/mL
  • No known CNS metastases
  • PATIENT CHARACTERISTICS:
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 12 weeks
  • Hematopoietic
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No known bleeding disorder
  • Hepatic
  • PT and PTT or INR normal
  • Bilirubin normal
  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No significant cardiac dysfunction
  • Other
  • Fertile patients must use effective contraception
  • No pre-existing peripheral neuropathy ≥ grade 2
  • No active, uncontrolled infection
  • No significant neurological disorder that would preclude study compliance
  • No history of other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer
  • PRIOR CONCURRENT THERAPY:
  • Chemotherapy
  • No prior chemotherapy except estramustine and recovered
  • No other concurrent chemotherapy
  • Endocrine therapy
  • See Disease Characteristics
  • At least 4 weeks since prior antiandrogens (6 weeks for bicalutamide)
  • Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued\* or restarted\* during study treatment to maintain castrate levels of testosterone NOTE: \*For patients receiving LHRH agonist therapy prior to study entry
  • Radiotherapy
  • At least 4 weeks since prior external beam radiotherapy except low-dose, nonmyelosuppressive radiotherapy
  • Must have had less than 25% of marrow irradiated
  • No prior strontium chloride Sr 89
  • No concurrent radiotherapy except low-dose, nonmyelosuppressive, palliative radiotherapy
  • Surgery
  • At least 2 weeks since prior major surgery
  • Other
  • At least 4 weeks since prior investigational agent
  • At least 4 weeks since prior anticancer therapy
  • No concurrent therapeutic anticoagulants except low-dose oral anticoagulants (i.e., 1 mg warfarin) or low molecular weight heparin
  • No other concurrent investigational agents
  • No other concurrent cytotoxic therapy

Exclusion

    Key Trial Info

    Start Date :

    September 28 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 18 2011

    Estimated Enrollment :

    82 Patients enrolled

    Trial Details

    Trial ID

    NCT00258388

    Start Date

    September 28 2005

    End Date

    January 18 2011

    Last Update

    August 4 2023

    Active Locations (13)

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

    Page 1 of 4 (13 locations)

    1

    University of Washington

    Seattle, Washington, United States, 98109

    2

    Tom Baker Cancer Centre

    Calgary, Canada, T2N 4N2

    3

    Cross Cancer Institute

    Edmonton, Canada, T6G 1Z2

    4

    QEII Health Sciences Center

    Halifax, Canada, B3H 1V7