EUCTR2004-002094-23-DE进行中（未招募）不适用
Randomized phase II trial of Docetaxel (Taxotere) and Oblimersen vs Taxotere alone in patients with HRPC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •? 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 Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at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
- 另有 2 项未显示
排除标准
- •Please refer to Inclusion Criteria above.
研究者
相似试验
进行中（未招募）
1 期
Randomized phase II trial of Docetaxel (Taxotere) and Oblimersen vs Taxotere alone in patients with HRPCPatients with Hormone- Refractory Prostate CancerMedDRA version: 7.0 Level: LLT Classification code 10001186EUCTR2004-002094-23-GBEORTC
进行中（未招募）
1 期
Randomized phase II trial of Docetaxel (Taxotere) and Oblimersen vs Taxotere alone in patients with HRPCPatients with Hormone- Refractory Prostate CancerMedDRA version: 7.0Level: LLTClassification code 10001186EUCTR2004-002094-23-HUEORTC
进行中（未招募）
2 期
A phase II trial of weekly docetaxel (Taxotere) for patients with relapsed ovarian cancer who have previously received paclitaxelRelapsed ovarian cancerCancer - Ovarian and primary peritonealACTRN12605000390684HMRC Clinical Trial Centre c/- Univ of Sydney60
已完成
2 期
Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (OOTR N003)JPRN-C000000322Organization for Oncology and Translational Research (OOTR)500
已完成
不适用
Randomized Phase II Trial Comparing Docetaxel with weekly Paclitaxel and Carboplatin in Elderly Patients with Non-Small Cell Lung CancerJPRN-UMIN000002616Tohoku University Hospital80