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| ID | Type | Description | Link |
|---|---|---|---|
| NOVARTIS-4244603011 |
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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug | |||
| quality-of-life assessment | Procedure |
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)
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knight, MD | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SORRA Research Center | Birmingham | Alabama | 35203 | United States | ||
| Brookwood ACCC |
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| 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 | 90095-1781 | 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 D.C. | 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 | 46885-5099 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Louisiana State University Medical Center | Lafayette | Louisiana | 70502-4016 | United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | 71130-3932 | 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 | St 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 | 07018-1095 | 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 |
| Albert Einstein Comprehensive Cancer Center | The Bronx | New York | 10461 | 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 |
| ID | Term |
|---|---|
| C562390 | Humoral Hypercalcemia Of Malignancy |
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D010146 | Pain |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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