Patients will have bone metastases with or without skeletal related events (SREs) from breast cancer and prostate cancer.
Conditions
Interventions
Trade Name: ZOMETA
Product Name: ZOMETA
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: zoledronic acid
Concentration unit: mg/g milligram(s)/gram
Concentration
Sponsors
Novartis Hungária Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent must be obtained Ambulatory patients at trial entry, aged 18 years or above (outpatients clinic having study treatment initiated in the hospital can be also eligible) Proof of breast cancer or prostate cancer Biopsy proof of breast cancer or prostate cancer in the medical history Diagnosis of at least one cancer-related bone lesion with or without SREs that is detectable on conventional radiographs of bone (plain film) or bone scan at screening. Patients with purely lytic, mixed lytic/sclerotic or purely sclerotic bone metastases are eligible. Breast cancer patients can be on first, second, or third-line hormonal therapy and on chemotherapy at trial entry. Life expectancy > 6 months. A negative pregnancy test for patients of childbearing potential ECOG performance status of 0, 1 or 2 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: Patients with abnormal renal function as evidenced by either serum creatinine > 1.5 X ULN or calculated creatinine clearance of 60 ml/minute or less Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) Patients with clinically symptomatic brain metastases Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates Pregnancy or lactation Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide) Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this prospective, single group, open label clinical study to assess the effects and tolerability of Zometa® (zoledronic acid), every 3-4 weeks, in patients with bone metastases from breast cancer, and prostate cancer. The primary objective of this study is to assess pain course over time measured by a visual analog scale (VAS). Patients who report pain upon entry into the trial will be evaluated for their course of pain. Patients who do not have pain upon entry into the trial will be evaluated for time to onset of pain. ;Secondary Objective: The secondary objectives of this trial include time in chair (infusion time), quality of life (Functional Assessment of Cancer Therapy Scale – General (FACT-G) and safety of Zometa® (zoledronic acid) administered every 3-4 weeks to cancer patients with bone metastases with or without SREs. ;Primary end point(s): Pain Assessments Pain will be documented each visit by each patient. Pain will be evaluated in mm based on a (100 mm) VAS-scale. The course of pain will be evaluated and will be presented graphically over the time of treatment. Pain will be summarized per visit and by time of infusion of Zometa®. Time to development of pain will be summarized using Kaplan-Meier curves for the group that reports no pain upon study entry. Results from tests for changes from baseline in pain will be analyzed by an ANOVA modeling. | — |
Countries
Hungary
Outcome results
None listed