EUCTR2005-002132-94-DE进行中（未招募）不适用
„Effect of intravenous Zoledronic Acid on Bone Metabolism given over 4 month in patients with prostate cancer or breast cancer and bone metastasis. A prospective, single-arm multicenter study” (ZoTect) - ZoTect
ovartis Pharma GmbH0 个研究点目标入组 405 人开始时间: 2005年11月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 405
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
- All
入选标准
- •- Histologically proven carcinoma of the prostate with evidence of at least one cancer
- •related bone lesion with or without hormonal treatment.
- •- Histologically proven carcinoma of the breast with evidence of at least one cancer
- •related bone lesion
- •- Negative pregnancy test at screening in case of child-bearing potential.
- •- Performance status ECOG 0-2
- •- Laboratory requirements: a) hepatic function: total bilirubin = 2,5 times the upper-
- •normal limit of the institution, SGPT, SGOT = 2,5 times the upper-normal limit of the
- •institution.
- •- Renal function: creatinine clearance more or equal 30 ml/min
- •- Normal cardiac function
- •- Life expectancy more or equal 6 months
- •- Signed informed consent prior to trial entry
- •- Patients of more or equal 18 years
- •- Patients must be accessible for treatment
- •- Standardized therapy for pre- und postmenopausal women is allowed
- •- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must
- •have elapsed since the completion of surgery, chemotherapy and radiotherapy to
- •breast or bone.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior treatment with bisphosphonates within 6 months before study start, and
- •during treatment with zoledronic acid
- •- No presence of at least one cancer-related bone lesion that is detectable on
- •conventional radiographs of bone or detectable on a bone scan and confirmed by
- •MRT or CT at screening
- •- Abnormal renal function as evidenced by
- •A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is
- •calculated using the Cockcroft-Gault formula:
- •CrCl = [[140-age (years)] x weight (kg)] / [72 x serum creatinine (mg/dL)]
- •{x 0.85 for female patients}
- •- Patients with clinically symptomatic brain metastases
- •- History of diseases with influence on bone metabolism such as Paget´s disease
- •and primary hyperparathyroidism and with need of treatment for osteoporosis
- •(defined according to DVO, T-Score =2.5).
- •- Severe physical or psychological concomitant diseases that expected to impair compliance with the provisions of the study protocol or impair the assessment of
- •drug of patient safety (clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG)
- •- Breast feeding or Pregnancy, confirmed by a positive serum hCG laboratory test (> 5 mIU/ml)
- •- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >25 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more medically acceptable methods of contraception.
- •- Known hypersensitivity to zoledronic acid or other bisphosphonates
- •- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or more or equal 12.0mg/dl (3.00 mmol/L)
- •- Known history or present abuse of alcohol or drugs
- •- Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
- •- Previous Radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month
- •- Prior malignancy except basal cell or squamous cell skin cancer or any other cancer from which the patient has been disease-free for more or equal 5 yrs.
- •- Use of other investigational drugs at the time of enrollment, or within 30 days before enrollment
- •- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
- •- Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
研究者
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