Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	Pharmaceutical / Industry	NOVARTIS-4244603011 NCT00003884

Objectives

I. Assess the safety and efficacy of zoledronate in patients with any solid 
tumor cancer with bone metastases other than breast or prostate cancer.

II. Assess the efficacy of zoledronate in preventing skeletal-related events 
including tumor induced hypercalcemia (TIH), time to first occurrence of 
skeletal-related event or TIH, skeletal morbidity rate, time to progression of 
bone metastases, overall survival, and time to overall disease progression in 
these patients.

III. Assess the quality of life and pain in these patients on these regimens.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed diagnosis of any cancer other than
breast cancer, multiple myeloma, or prostate cancer 
  Objective evidence of bone metastases discovered within 6 weeks of study     
   entry (patients who at screening present with an ECOG score of 2)
  No study entry restrictions for bone metastases for patients with an ECOG of 
   0 and 1

 No symptomatic brain metastases

Prior/Concurrent Therapy:

Biologic therapy:
 Concurrent biologic response modifier therapies allowed
 Concurrent marketed cytokine or colony stimulating factor therapies allowed
Chemotherapy:
 Concurrent marketed chemotherapy agents allowed (including open label         
  cooperative trials or for supportive care)

Endocrine therapy:
 Concurrent hormonal agents and steroid therapies allowed
 Concurrent corticosteroid therapy allowed (for chemotherapy induced           
  nausea/vomiting or spinal compression)

Radiotherapy:
 Concurrent radiotherapy to treat extraskeletal and/or skeletal tumor sites    
  allowed

Surgery:
 Prior surgery to treat or prevent pathological fracture or spinal cord        
  compression allowed

Other:
 At least 30 days since other prior investigational drugs 
 No concurrent bisphosphonate agent 
 At least 30 days since prior bisphosphonate agent (single exposure allowed    
  within prior 12 months)

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-2

Life expectancy:
 Not specified 

Hematopoietic:
 Not specified

Hepatic:
 Bilirubin no greater than 2.5 mg/dL for liver metastases

Renal:
 Creatinine no greater than 3.0 mg/dL
 Calcium at least 8.0 mg/dL but less than 12.0 mg/dL

Cardiovascular:
 No history of severe cardiovascular disease within past 6 months (e.g.,       
  congestive heart failure)
 No hypertension refractory to treatment
 No symptomatic coronary artery disease

Other:
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception 
 No history of noncompliance to medical regimen

Expected Enrollment

A total of 600 patients will be accrued for this study within 12 months.

Outline

This is a randomized, double blind, placebo controlled, multicenter study. 
Patients are stratified into two groups: patients with lung cancer and 
patients with all other solid tumor cancers.

Patients are randomly assigned to receive 1 of the following treatments:

Arm I: Patients receive intravenous zoledronate over 5 minutes every 3 weeks 
for 9 months.

Arm II: Patients receive intravenous zoledronate at a higher dose over 5 
minutes every 3 weeks for 9 months.

Arm III: Patients receive intravenous placebo over 5 minutes every 3 weeks for 
9 months.

All patients receive oral calcium daily, and an oral multivitamin supplement.

Quality of life is assessed prior to therapy, then at months 3, 6, and 9.

Patients are followed every 6 months for survival.

Trial Contact Information

Trial Lead Organizations

Novartis Pharmaceuticals Corporation

Robert Knight, MD, Protocol chair		Ph: 973-781-2792

Registry Information
Official Title		A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zoledronate (4 and 8 mg) Administered Intravenously as an Adjuvant to Anticancer Therapy to Patients with any Cancer with Bone Metastases Other than Breast Cancer, Multiple Myeloma or Prostate Cancer
Trial Start Date		1998-08-14
Registered in ClinicalTrials.gov		NCT00003884
Date Submitted to PDQ		1999-04-30
Information Last Verified		2007-05-31