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Clinical Trials/EUCTR2004-002094-23-GB
EUCTR2004-002094-23-GBActive, not recruitingPhase 1

Randomized phase II trial of Docetaxel (Taxotere) and Oblimersen vs Taxotere alone in patients with HRPC

EORTC0 sites0 target enrollmentStarted: February 23, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
EORTC
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •? Histologically proven prostate adenocarcinoma
  • •? Hormone refractory prostate cancer defined as progression under prior hormonal treatment with
  • •LH-RH analogues or orchiectomy and anti-androgens, given either together or consecutively.
  • •? Progressive disease is defined as PSA progression documented by 2 increased PSA values over
  • •a previous reference value. PSA fluctuations should be handled as defined in chapter 7.1.
  • •? Patients must have a demonstrated continued elevation of PSA for at least 6 weeks after
  • •discontinuation of antiandrogens prior to registration on study
  • •? PSA greater or equal to 5 ng/ml (hybritech or equivalent) within 1 week prior to randomisation
  • •? No clinical evidence of brain metastases
  • •? No evidence of painful and/or destructive bone metastases for which radiation therapy,
  • •bisphosphonates or bone-seeking radionucleides are considered necessary by the treating
  • •physician. Other bone metastases are allowed.
  • •? Age =18 years
  • •? WHO Performance status 0-2
  • •? No regular (daily) intake of opioid analgesics
  • •? No prior treatment with chemotherapy, bone-seeking radionucleides or radiotherapy involving
  • •more than 25% of marrow producing area. (Prior use of Estramustine phosphate and/or
  • •bisphosponates are allowed).
  • •? No prior hormonal manipulation with PC-SPES within the last 6 weeks prior to entry on study
  • •? Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at
  • •least 6 weeks prior to randomization.
  • •? No concurrent treatment with other experimental drugs or anti-cancer drugs (except LH-RH
  • •agonist) nor bisphosphonates.
  • •? Castrate level of testosterone (<= 50 ng/mL). Patients with medical castration with LHRH
  • •analogue must continue LHRH analogue
  • •? Adequate venous access
  • •? Adequate hematological functions as assessed by Hb = 10 g/dl WBC = 3.500 109/l, ANC = 1.5
  • •109/l , and platelets = 100 109/l.
  • •? Adequate liver function as assessed by bilirubin = upper limit of the normal range (UNL) and
  • •ASAT = 1.5 x UNL and ALAT = 1.5 x UNL
  • •? Adequate renal function as assessed by serum creatinine = 1.5 xULN or calculated creatinine
  • •clearance = 50 ml/min according to Cockcroft formula. (see Appendix C for the formula)
  • •? Partial thromboplastin time (PTT) <= 1.5xUNL and Prothrombin time (PT) <=1.5xUNL (or
  • •INR<=1.3)
  • •? No known hypersensitivity to oligonucleotides or any component of the oblimersen formulation
  • •or to drugs formulated with polysorbate. No hypersensitivity to phosphorothioates.
  • •? No CVA or transient ischemic attack or myocardial infarction attacks within the past 6 months
  • •? No active infection, no known HIV
  • •? No history of interstitial pneumonitis or pulmonary fibrosis
  • •? No unstable angina or pulmonary embolism, no uncontrolled hypertension
  • •? No history of deep venous thrombosis within 6 months prior to entry on study
  • •? No pre-existing neuropathy

Exclusion Criteria

  • •Please refer to Inclusion Criteria above.

Investigators

Sponsor
EORTC

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