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

February 20, 2013 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Comprehensive Cancer Center
      • Birmingham, Alabama, United States, 35203
        • SORRA Research Center
      • Birmingham, Alabama, United States, 35209
        • Brookwood ACCC
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • California
      • Gilroy, California, United States, 95020
        • Columbia South Valley Hospital
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90073
        • Veterans Affairs Medical Center - West Los Angeles
      • Poway, California, United States, 92064
        • Southwest Cancer Care
      • Rancho Mirage, California, United States, 92270
        • Cancer and Blood Institute of the Desert
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Oncology Clinic, P.C.
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Vincent T. Lombardi Cancer Research Center, Georgetown University
    • Florida
      • Miami, Florida, United States, 33125
        • Veterans Affairs Medical Center - Miami
      • Miami, Florida, United States, 33176
        • Oncology-Hematology Group of South Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • American Medical Research Institute, Inc.
    • Illinois
      • Belleville, Illinois, United States, 62226
        • Oncology Care Center - Belleville
    • Indiana
      • Fort Wayne, Indiana, United States, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Inc.
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • Lafayette, Louisiana, United States, 70502-4016
        • Louisiana State University Medical Center
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine and Blood Disorders
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center and Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center Hospital
      • Wellesley, Massachusetts, United States, 02181
        • New England Hematology/Oncology Associates, P.C.
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health and DeVos Children's Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's/Duluth Clinic Health System
      • Robbinsdale, Minnesota, United States, 55422
        • Hubert H. Humphrey Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Kansas City Internal Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
    • Nevada
      • Reno, Nevada, United States, 89520
        • Veterans Affairs Medical Center - Reno
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center
      • Brooklyn, New York, United States, 11212
        • Brookdale University Hospital and Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital - Cornell Campus
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Raleigh Internal Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Cancer Center
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73190
        • University of Oklahoma College of Medicine
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Regional Cancer Center - Erie
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Cancer Institute
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Palmetto Hematology/Oncology Associates
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • Dial Research Associates
      • Memphis, Tennessee, United States, 38103
        • Methodist Hospitals of Memphis
    • Texas
      • Corpus Christi, Texas, United States, 78412
        • Cancer Specialist of South Texas. P.A.
      • Tyler, Texas, United States, 75710
        • University of Texas Health Center at Tyler
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Huntsman Cancer Institute
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Hematology and Oncology, Inc.
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Robert Knight, MD, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (Actual)

January 1, 2001

Study Completion (Actual)

January 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 21, 2004

First Posted (Estimate)

July 22, 2004

Study Record Updates

Last Update Posted (Estimate)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067052
  • NOVARTIS-4244603011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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