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Status:

COMPLETED

Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel b...

Detailed Description

OBJECTIVES: Primary * Compare the activity of docetaxel with or without oblimersen, in terms of prostate-specific antigen response, in patients with hormone-refractory adenocarcinoma of the prostate...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the prostate
  • Hormone-refractory disease
  • Disease progression after prior hormonal therapy with luteinizing hormone-releasing hormone (LH-RH) analogues or orchiectomy and antiandrogens (given together or consecutively)
  • Prostate-specific antigen (PSA) progression documented by at least 2 increases in PSA values over previous PSA reference value
  • Must demonstrate continued PSA elevation for at least 6 weeks after discontinuation of antiandrogen therapy
  • PSA ≥ 5 ng/mL (Hybritech or equivalent) within the past week
  • Testosterone ≤ 0.5 ng/mL\* NOTE: \*Patients with medical castration with LH-RH analogue must continue with LH-RH analogue throughout the study
  • No evidence of painful and/or destructive bone metastases requiring concurrent radiotherapy, bisphosphonates, or bone-seeking radionuclides
  • Other bone metastases allowed
  • No clinical evidence of brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • WBC ≥ 3,500/mm\^3
  • Hemoglobin ≥ 10 g/dL
  • Hepatic
  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ ULN
  • PTT and PT ≤ 1.5 times ULN OR
  • INR ≤ 1.3
  • Renal
  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 50 mL/min
  • Cardiovascular
  • No unstable angina
  • No uncontrolled hypertension
  • No deep venous thrombosis within the past 6 months
  • No cerebrovascular accident, transient ischemic attack, or myocardial infarction within the past 6 months
  • Pulmonary
  • No pulmonary embolism
  • No history of interstitial pneumonitis
  • No history of pulmonary fibrosis
  • Other
  • Adequate venous access
  • HIV negative
  • No active infection
  • No pre-existing neuropathy
  • No hypersensitivity to phosphorothioates
  • No hypersensitivity to oligonucleotides or any other component of the oblimersen formulation or to drugs formulated with polysorbate
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • No other malignancy within the past 5 years except adequately treated superficial urothelial or skin cancer
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • Prior estramustine allowed
  • No other prior chemotherapy
  • No concurrent estramustine
  • Endocrine therapy
  • See Disease Characteristics
  • At least 6 weeks since prior flutamide, bicalutamide, or nilutamide
  • More than 6 weeks since prior hormonal manipulation with PC-SPES
  • Concurrent LH-RH agonist allowed
  • No concurrent antiandrogens
  • Radiotherapy
  • See Disease Characteristics
  • No prior radiotherapy involving \> 25% of marrow-producing area
  • No prior bone-seeking radionuclides
  • No concurrent radiotherapy (including palliative therapy for painful bone metastases)
  • No concurrent bone-seeking radionuclides
  • Surgery
  • See Disease Characteristics
  • Other
  • Prior bisphosphonates allowed
  • No concurrent anticoagulation except for low-dose warfarin (1 mg/day)
  • No concurrent regular (daily) intake of opioid analgesics
  • No other concurrent experimental drugs or anticancer drugs
  • No concurrent bisphosphonates

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    116 Patients enrolled

    Trial Details

    Trial ID

    NCT00085228

    Start Date

    April 1 2004

    Last Update

    September 24 2012

    Active Locations (16)

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

    Page 1 of 4 (16 locations)

    1

    Kaiser Franz Josef Hospital

    Vienna, Austria, A-1100

    2

    Onze Lieve Vrouw Ziekenhuis Aalst

    Aalst, Belgium, B-9300

    3

    Institut Jules Bordet

    Brussels, Belgium, 1000

    4

    Cliniques Universitaires Saint-Luc

    Brussels, Belgium, 1200