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

NCT00172003 | Completed Phase 4 DMC

• 1 other identifier: CZOL446EDE15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Cancer; Neoplasm Metastasis

Keywords

Renal Cell Cancer; Bone metastasis; Skeletal related event; Renal Cell Cancer patients with bone metastasis

Outcome Measures

Primary Outcomes (1)

• Rate of skeletal complications

  continuous

Secondary Outcomes (5)

• Time to first skeletal complication

  from first application of Zometa until confirmed skeletal related event (SRE)

• Bone pain

  every 9 weeks

• Time to overall progression of disease

  continuous

• Overall survival

  continuous

• Bone turnover parameters

  every 9 weeks

Study Arms (1)

Zoledronic acid

EXPERIMENTAL

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

Interventions

Zoledronic acid DRUG

Zoledronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A histologically confirmed diagnosis of renal cell carcinoma with none, one or, at maximum, 2 of the following risk factors:
• Karnofsky performance status less than 80%
• Lactate dehydrogenase greater than 1.5 times upper limit of normal
• Hemoglobin less than lower limit of normal
• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis investigative Site

Offenbach, Germany

Location

Related Publications (1)

• Tunn UW, Stenzl A, Schultze-Seemann W, Strauss A, Kindler M, Miller K, Wirth MP, Zantl N, Schulze M, May C, Ruebel A, Birkholz K, Gruenwald V. Positive effects of zoledronate on skeletal-related events in patients with renal cell cancer and bone metastases. Can J Urol. 2012 Jun;19(3):6261-7.

  PMID: 22704310 RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2004
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

DE (1)