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NCT00003884 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003884
Other study ID # CDR0000067052
Secondary ID NOVARTIS-4244603
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated February 20, 2013
Start date August 1998
Est. completion date January 2001

Study information
Verified date February 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Zoledronate may help to relieve some of the symptoms caused by bone metastases. It is not yet known if zoledronate is more effective than no further therapy in relieving symptoms of bone metastases or preventing disease progression.

PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in treating patients who have solid tumors that have spread to the bone.

Description:

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.

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.

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

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date January 2001
Est. primary completion date January 2001
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

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)

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• zoledronic acid

Procedure:
• quality-of-life assessment

Locations
Country Name City State
United States American Medical Research Institute, Inc. Atlanta Georgia
United States Greater Baltimore Medical Center and Cancer Center Baltimore Maryland
United States Oncology Care Center - Belleville Belleville Illinois
United States Brookwood ACCC Birmingham Alabama
United States SORRA Research Center Birmingham Alabama
United States University of Alabama Comprehensive Cancer Center Birmingham Alabama
United States New England Medical Center Hospital Boston Massachusetts
United States Dial Research Associates Brentwood Tennessee
United States Albert Einstein Comprehensive Cancer Center Bronx New York
United States Brookdale University Hospital and Medical Center Brooklyn New York
United States Cleveland Clinic Cancer Center Cleveland Ohio
United States Oncology Clinic, P.C. Colorado Springs Colorado
United States Hematology Oncology Consultants Inc Columbus Ohio
United States Cancer Specialist of South Texas. P.A. Corpus Christi Texas
United States Danville Hematology and Oncology, Inc. Danville Virginia
United States Veterans Affairs Medical Center - Denver Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States St. Mary's/Duluth Clinic Health System Duluth Minnesota
United States Veterans Affairs Medical Center - East Orange East Orange New Jersey
United States Regional Cancer Center - Erie Erie Pennsylvania
United States Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne Indiana
United States Columbia South Valley Hospital Gilroy California
United States Spectrum Health and DeVos Children's Hospital Grand Rapids Michigan
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Kansas City Internal Medicine Kansas City Missouri
United States Louisiana State University Medical Center Lafayette Louisiana
United States Pacific Shores Medical Group Long Beach California
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States Veterans Affairs Medical Center - West Los Angeles Los Angeles California
United States North Shore University Hospital Manhasset New York
United States Methodist Hospitals of Memphis Memphis Tennessee
United States Oncology-Hematology Group of South Florida Miami Florida
United States Veterans Affairs Medical Center - Miami Miami Florida
United States Ochsner Clinic New Orleans Louisiana
United States New York Presbyterian Hospital - Cornell Campus New York New York
United States University of Oklahoma College of Medicine Oklahoma City Oklahoma
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States Southwest Cancer Care Poway California
United States Raleigh Internal Medicine Raleigh North Carolina
United States Cancer and Blood Institute of the Desert Rancho Mirage California
United States Veterans Affairs Medical Center - Reno Reno Nevada
United States Hubert H. Humphrey Cancer Center Robbinsdale Minnesota
United States University of Rochester Cancer Center Rochester New York
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Huntsman Cancer Institute Salt Lake City Utah
United States Maine Center for Cancer Medicine and Blood Disorders Scarborough Maine
United States Swedish Cancer Institute Seattle Washington
United States Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana
United States Palmetto Hematology/Oncology Associates Spartanburg South Carolina
United States Highlands Oncology Group Springdale Arkansas
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States University of Texas Health Center at Tyler Tyler Texas
United States Vincent T. Lombardi Cancer Research Center, Georgetown University Washington District of Columbia
United States New England Hematology/Oncology Associates, P.C. Wellesley Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

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