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

NCT00003884 | Completed Phase 3

• 2 other identifiers: CDR0000067052NOVARTIS-4244603011
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 55

Brief 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.

Conditions

Hypercalcemia of Malignancy; Lung Cancer; Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

hypercalcemia of malignancy; pain; recurrent non-small cell lung cancer; recurrent small cell lung cancer; unspecified adult solid tumor, protocol specific; bone metastases

Interventions

zoledronic acid DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

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

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Novartis: lead

Study Sites (55)

SORRA Research Center

Birmingham, Alabama, 35203, United States

Location

Brookwood ACCC

Birmingham, Alabama, 35209, United States

Location

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72764, United States

Location

Columbia South Valley Hospital

Gilroy, California, 95020, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Veterans Affairs Medical Center - West Los Angeles

Los Angeles, California, 90073, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Southwest Cancer Care

Poway, California, 92064, United States

Location

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Oncology Clinic, P.C.

Colorado Springs, Colorado, 80909, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Veterans Affairs Medical Center - Miami

Miami, Florida, 33125, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

American Medical Research Institute, Inc.

Atlanta, Georgia, 30338, United States

Location

Oncology Care Center - Belleville

Belleville, Illinois, 62226, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Louisiana State University Medical Center

Lafayette, Louisiana, 70502-4016, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, 21204, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

New England Hematology/Oncology Associates, P.C.

Wellesley, Massachusetts, 02181, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Spectrum Health and DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

St. Mary's/Duluth Clinic Health System

Duluth, Minnesota, 55805, United States

Location

Hubert H. Humphrey Cancer Center

Robbinsdale, Minnesota, 55422, United States

Location

Kansas City Internal Medicine

Kansas City, Missouri, 64132, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

Veterans Affairs Medical Center - Reno

Reno, Nevada, 89520, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Raleigh Internal Medicine

Raleigh, North Carolina, 27609, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

Hematology Oncology Consultants Inc

Columbus, Ohio, 43235, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Regional Cancer Center - Erie

Erie, Pennsylvania, 16505, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Palmetto Hematology/Oncology Associates

Spartanburg, South Carolina, 29303, United States

Location

Dial Research Associates

Brentwood, Tennessee, 37027, United States

Location

Methodist Hospitals of Memphis

Memphis, Tennessee, 38103, United States

Location

Cancer Specialist of South Texas. P.A.

Corpus Christi, Texas, 78412, United States

Location

University of Texas Health Center at Tyler

Tyler, Texas, 75710, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Danville Hematology and Oncology, Inc.

Danville, Virginia, 24541, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Humoral Hypercalcemia Of Malignancy; Lung Neoplasms; Neoplasm Metastasis; Pain; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Robert Knight, MD

  Novartis Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 22, 2004
• Study Start: August 1, 1998
• Primary Completion: January 1, 2001
• Study Completion: January 1, 2001
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

US (55)