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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 210

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 Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at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
? No second primary cancer (except adequately treated superficial urothelial or skin cancer
without signs of recurrence in the past 5 years)
? Absence of any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions should
be discussed with the patient before registration in the trial
? Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Patients can only be randomized in this trial once
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (1

Exclusion Criteria

Please refer to Inclusion Criteria above.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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