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Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase IV
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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CZOL446EDE15
NCT00172003
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Trial Description
Summary It is the aim of this clinical study to evaluate the skeletal-related event rate under therapy with zoledronic acid in patients with renal cell cancer having at least one cancer-related bone lesion. Eligibility Criteria Inclusion Criteria: - A histologically confirmed diagnosis of renal cell carcinoma with none, one or, at maximum, 2 of the following risk factors:
1. Karnofsky performance status less than 80% 2. Lactate dehydrogenase greater than 1.5 times upper limit of normal 3. Hemoglobin less than lower limit of normal 4. Absence of nephrectomy - Patients must have evidence of at least one cancer-related bone lesion. If diagnosis of bone metastases in bone scan or magnetic resonance imaging (MRI)-QuickScan is unclear radiographic (X-ray, computed tomography [CT] or MRI) confirmation of at least one focus is required.
- ECOG performance status of 0, 1 or 2.
- Life expectancy of ≥ 6 months
- Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
Exclusion Criteria: - Bisphosphonate treatment within 6 months before study start
- Bone pain which requires strong narcotic therapy with centrally acting analgesic agents.
- Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 3 months prior to Visit 2.
- 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) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)]
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)
- Patients with clinically symptomatic brain metastases
- History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
- Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, intrauterine device [IUD], vaginal diaphragm or sponge, or condom with spermicide)
- Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion
- 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)
Other protocol-defined inclusion and exclusion criteria may apply.
Trial Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation | Novartis | | Study Chair |
| Novartis | | Ph: 41 61 324 1111 |
Trial Sites
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| Germany |
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Offenbach |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00172003
Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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