Patients with Hormone- Refractory Prostate Cancer MedDRA version: 7.0 Level: LLT Classification code 10001186
Conditions
Interventions
Trade Name: Taxotere
Product Name: docetaxel
Product Code: docetaxel
Pharmaceutical Form: Solution for injection
Product Name: Genasense
Product Code: G3139
Pharmaceutical Form: Solution for infusion
Sponsors
EORTC
Eligibility
Sex/Gender
Male
Inclusion 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 Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at least 6 weeks prior to randomization.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 ? 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
Exclusion criteria: Please refer to Inclusion Criteria above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a randomized phase II trial to evaluate the toxicity and activity (in terms of PSA response) of the combination of docetaxel and oblimersen in hormone refractory prostate cancer. The trial is randomized against docetaxel alone which will serve as a reference group to further validate the sample used in the trial.;Secondary Objective: time to progression, toxicity, survival;Primary end point(s): Primary Endpoints 1. PSA response defined as a 50% decline from baseline value confirmed by a second value obtained at least 4 weeks apart according to Bubley criteria 2. Occurrence of Major toxic events Any grade 4 haematological and non hematological toxicity except asymptomatic grade 4 neutropenia (ANC 5 days or any Grade 4 febrile neutropenia sepsis (=grade 3 or 4) Severe (grade 3 or 4) hemorrhage-bleeding associated with grade>2 thrombocytopenia ( 3xULN or need of dialysis) · Stop of treatment due to unacceptable toxicity · Death at least possibly due to toxicity | — |
Countries
Germany, Hungary, Spain, United Kingdom
Outcome results
None listed