Patients with prostate or breast cancer with bone metastasis MedDRA version: 9.1 Level: LLT Classification code 10036910 Term: Prostate cancer NOS
Conditions
Interventions
Trade Name: Zometa
Product Code: ZOL446
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Zoledronic acid
CAS Number: 118072-93-8
Current Sponsor code: ZOL446
Concentrati
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess course of bone turn-over markers (PINP, bALP, ICTP and CTX);Secondary Objective: - Relationship between tumour burden/metastatic sites assessed by bone scan Soloway Score (63)) and level of bone markers at study entry - Pain assessment (VAS) and analgesics score - Relationship between Pain and course of bone turn-over markers - Rate of SREs - Relationship between SREs and bone turnover markers - Quality of life questionnaire (EORTC 30) - Course of PSA (Patients with prostate cancer only) - Course of urinary NTX ( in centers where storage at -20°C is possible) - Safety and Tolerability (adverse events (AEs), serious adverse events (SAEs)) ;Primary end point(s): Assessment of the effect of Zoledronic Acid given every 4 weeks for 4 months on bone metabolism. Assessment will carried out by the course of bone turn-over markers. | — |
Countries
Germany
Outcome results
None listed