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Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
This study is currently recruiting participants.
Verified by Novartis, May 2008
First Received: September 13, 2005   Last Updated: May 1, 2008   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00172003
  Purpose

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.


Condition Intervention Phase
Renal Cell Cancer
Neoplasm Metastasis
Drug: Zoledronic acid
Phase IV

MedlinePlus related topics: Cancer
Drug Information available for: Zoledronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of skeletal complications

Secondary Outcome Measures:
  • Time to first skeletal complication
  • Bone pain
  • Time to overall progression of disease
  • Overall survival
  • Bone turnover parameters

Estimated Enrollment: 100
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Pregnancy and lactation
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00172003

Contacts
Contact: Novartis 41 61 324 1111

Locations
Germany
Recruiting
Offenbach, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Study ID Numbers: CZOL446EDE15
Study First Received: September 13, 2005
Last Updated: May 1, 2008
ClinicalTrials.gov Identifier: NCT00172003     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Renal Cell Cancer
Bone metastasis
Skeletal related event
Renal Cell Cancer patients with bone metastasis

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Zoledronic acid
Bone Density Conservation Agents
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Diphosphonates
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Neoplasm Metastasis
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Zoledronic acid
Neoplasms by Histologic Type
Physiological Effects of Drugs
Bone Density Conservation Agents
Urogenital Neoplasms
Urologic Neoplasms
Pharmacologic Actions
Carcinoma
Neoplastic Processes
Neoplasms
Diphosphonates
Pathologic Processes
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasm Metastasis
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009