Breast Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility 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

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 is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT00003884

Recruitment Status:

Completed

Sponsor:

Novartis

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There are 55 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

600

Study ID:

NCT00003884

Recruitment Status:

Completed

Sponsor:


Novartis

How clear is this clinincal trial information?

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