Safety and Efficacy Study of Concomitant Radiotherapy and Zoledronic Acid for Bone Metastases Palliation

NCT00264420 | Completed Phase 1

• 2 other identifiers: IRB7743Case 8Y04
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates are used in bone metastases to keep the cancerous lesion under control in the bone and to help prevent calcium level elevations in the blood. Cancer cell-culture studies at the Cleveland Clinic showed that zoledronic acid and radiation together have more cell killing effect than either one used alone. The purpose of this study is to monitor the healing of bone lesions when using zoledronic acid together with radiation treatment.

Conditions

Bone Metastases; Breast Cancer; Lung Cancer; Prostate Cancer

Keywords

bone metastases; breast cancer; lung cancer; prostate cancer; zoledronic acid; radiation therapy

Outcome Measures

Primary Outcomes (1)

• PET-CT

  baseline and 6 months

Secondary Outcomes (3)

• X-ray, baseline

  3 months, 6 months

• physical exam

  Radiaton Oncology - visits 1, 14, 17

• physical exam

  Medical Oncology - visits 1, 13, 17

Study Arms (1)

1

EXPERIMENTAL

zoledronic acid plus radiation therapy

Drug: zoledronic acid

Interventions

zoledronic acid DRUG

At baseline 4 mg IV zoledronic acid over 15 min. every 4 weeks for 6 months plus radiation therapy 30 Gy in 10 fractions (5 times per week for first two weeks)

1

Eligibility Criteria

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

You may qualify if:

• \>18 years of age
• biopsy proven breast, lung, and/or prostate cancer
• boney metastases with an indication for radiation, either diagnosed radiologically or biopsy proven
• Karnofsky Performance Status \>60
• Life expectancy of at least 6 months
• Serum creatinine level ≤ 2.0 mg/dL and calculated creatinine clearance of \> 60 mL/min
• Leukocyte count ≥ 3500/mm3
• Hemoglobulin \> 11 g/dl
• Platelets \> 100,000 / mm3
• Total bilirubin \< 2.5 mg/dl

You may not qualify if:

• pregnant and lactating women (breast and lung cancer)
• hormonotherapy started less than 3 months prior to randomization (prostate cancer)
• history of allergic reactions to bisphosphonates
• receiving concomitant nephrotoxic chemotherapy
• participation in another clinical trial with an investigational drug or completed an investigational drug trial within the past 30 days
• liver function tests \> 1.5 times normal values
• IV calcitonin administration less than 30 days prior to randomization
• laboratory evidence of renal disease
• previous RT to the region of bone metastasis which will be treated in this study
• currently receiving oral or IV bisphosphonate therapy
• presence of ascites
• clinically significant electrocardiographic changes
• hypercalcemia, pathologic fracture, or epidural spinal cord compression
• other organ metastasis
• known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Novartis: collaborator

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MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Roger Macklis, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 12, 2005
• Study Start: December 1, 2005
• Study Completion: March 1, 2007
• Last Updated: December 21, 2010

Record last verified: 2010-12