Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama Comprehensive Cancer Center
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Birmingham、Alabama、美国、35203
- SORRA Research Center
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Birmingham、Alabama、美国、35209
- Brookwood ACCC
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Arkansas
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Springdale、Arkansas、美国、72764
- Highlands Oncology Group
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California
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Gilroy、California、美国、95020
- Columbia South Valley Hospital
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Long Beach、California、美国、90813
- Pacific Shores Medical Group
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Los Angeles、California、美国、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles、California、美国、90073
- Veterans Affairs Medical Center - West Los Angeles
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Poway、California、美国、92064
- Southwest Cancer Care
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Rancho Mirage、California、美国、92270
- Cancer and Blood Institute of the Desert
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Colorado
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Colorado Springs、Colorado、美国、80909
- Oncology Clinic, P.C.
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Denver、Colorado、美国、80220
- Veterans Affairs Medical Center - Denver
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District of Columbia
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Washington、District of Columbia、美国、20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Miami、Florida、美国、33125
- Veterans Affairs Medical Center - Miami
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Miami、Florida、美国、33176
- Oncology-Hematology Group of South Florida
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Tampa、Florida、美国、33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta、Georgia、美国、30338
- American Medical Research Institute, Inc.
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Illinois
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Belleville、Illinois、美国、62226
- Oncology Care Center - Belleville
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Indiana
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Fort Wayne、Indiana、美国、46885-5099
- Fort Wayne Medical Oncology and Hematology, Inc.
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa Hospitals and Clinics
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Louisiana
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Lafayette、Louisiana、美国、70502-4016
- Louisiana State University Medical Center
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New Orleans、Louisiana、美国、70121
- Ochsner Clinic
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Shreveport、Louisiana、美国、71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Maine
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Scarborough、Maine、美国、04074
- Maine Center for Cancer Medicine and Blood Disorders
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Maryland
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Baltimore、Maryland、美国、21204
- Greater Baltimore Medical Center and Cancer Center
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Massachusetts
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Boston、Massachusetts、美国、02111
- New England Medical Center Hospital
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Wellesley、Massachusetts、美国、02181
- New England Hematology/Oncology Associates, P.C.
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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Grand Rapids、Michigan、美国、49503
- Spectrum Health and DeVos Children's Hospital
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Minnesota
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Duluth、Minnesota、美国、55805
- St. Mary's/Duluth Clinic Health System
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Robbinsdale、Minnesota、美国、55422
- Hubert H. Humphrey Cancer Center
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Missouri
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Kansas City、Missouri、美国、64132
- Kansas City Internal Medicine
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Saint Louis、Missouri、美国、63131
- Missouri Baptist Cancer Center
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Nevada
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Reno、Nevada、美国、89520
- Veterans Affairs Medical Center - Reno
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New Jersey
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East Orange、New Jersey、美国、07018-1095
- Veterans Affairs Medical Center - East Orange
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New York
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Bronx、New York、美国、10461
- Albert Einstein Comprehensive Cancer Center
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Brooklyn、New York、美国、11212
- Brookdale University Hospital and Medical Center
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Manhasset、New York、美国、11030
- North Shore University Hospital
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New York、New York、美国、10021
- New York Presbyterian Hospital - Cornell Campus
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Rochester、New York、美国、14642
- University of Rochester Cancer Center
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North Carolina
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Raleigh、North Carolina、美国、27609
- Raleigh Internal Medicine
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Cancer Center
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Columbus、Ohio、美国、43235
- Hematology Oncology Consultants Inc
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Oklahoma
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Oklahoma City、Oklahoma、美国、73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Erie、Pennsylvania、美国、16505
- Regional Cancer Center - Erie
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Hershey、Pennsylvania、美国、17033
- Milton S. Hershey Medical Center
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Cancer Institute
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South Carolina
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Spartanburg、South Carolina、美国、29303
- Palmetto Hematology/Oncology Associates
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Tennessee
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Brentwood、Tennessee、美国、37027
- Dial Research Associates
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Memphis、Tennessee、美国、38103
- Methodist Hospitals of Memphis
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Texas
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Corpus Christi、Texas、美国、78412
- Cancer Specialist of South Texas. P.A.
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Tyler、Texas、美国、75710
- University of Texas Health Center at Tyler
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Utah
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Salt Lake City、Utah、美国、84132
- Huntsman Cancer Institute
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Virginia
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Danville、Virginia、美国、24541
- Danville Hematology and Oncology, Inc.
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Washington
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Seattle、Washington、美国、98104
- Swedish Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
合作者和调查者
赞助
调查人员
- 学习椅：Robert Knight, MD、Novartis Pharmaceuticals
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.