A multicenter, Open-label Study to Determine the Effect of I.V. Zometa on Pain and Quality of Life in Patients with Bone Metastases with or without Skeletal Related Events (SREs) Resulting from Breast Cancer and Prostate Cancer
- Conditions
- Patients will have bone metastases with or without skeletal related events (SREs) from breast cancer and prostate cancer.
- Registration Number
- EUCTR2004-005088-17-HU
- Lead Sponsor
- ovartis Hungária Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method