Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00172003
First received: September 13, 2005
Last updated: August 6, 2012
Last verified: August 2012
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of skeletal complications [ Time Frame: continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first skeletal complication [ Time Frame: from first application of Zometa until confirmed skeletal related event (SRE) ] [ Designated as safety issue: No ]
  • Bone pain [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]
  • Time to overall progression of disease [ Time Frame: continuous ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: continuous ] [ Designated as safety issue: No ]
  • Bone turnover parameters [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic acid
Zoledronic acid, dosage according to calculated creatinine clearance, administered as a 15 minute infusion every 3 weeks for 12 months. Study infusion visits should occur not earlier than the scheduled visit and no later than 3 days after the scheduled visit. The dose of zoledronic acid in patients with baseline creatinine clearance > 60 mL/min was recommended to be 4 mg infused over no less than 15 minutes.
Drug: Zoledronic acid

  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
  • Patient has given written informed consent prior to any study-specific procedures

Exclusion Criteria:

  • Only patients who received 3 or less applications of an i.v. Bisphosphonate in the past are eligible
  • Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) is allowed. However, other loci of bone metastasis must be present, which were not treated with radiation therapy and thus can be assessed for primary and secondary endpoints.
  • 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
  • Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG.
  • Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
  • 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
  • Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion
  • Participation in another trial
  • Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
  • Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Novartis investigative Site
Offenbach, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00172003     History of Changes
Other Study ID Numbers: CZOL446EDE15
Study First Received: September 13, 2005
Last Updated: August 6, 2012
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

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

ClinicalTrials.gov processed this record on July 23, 2014