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.
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.
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)
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There are 55 Locations for this study
Birmingham Alabama, 35203, United States
Birmingham Alabama, 35209, United States
Birmingham Alabama, 35294, United States
Springdale Arkansas, 72764, United States
Gilroy California, 95020, United States
Long Beach California, 90813, United States
Los Angeles California, 90073, United States
Los Angeles California, 90095, United States
Poway California, 92064, United States
Rancho Mirage California, 92270, United States
Colorado Springs Colorado, 80909, United States
Denver Colorado, 80220, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33125, United States
Miami Florida, 33176, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30338, United States
Belleville Illinois, 62226, United States
Fort Wayne Indiana, 46885, United States
Iowa City Iowa, 52242, United States
Lafayette Louisiana, 70502, United States
New Orleans Louisiana, 70121, United States
Shreveport Louisiana, 71130, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21204, United States
Boston Massachusetts, 02111, United States
Wellesley Massachusetts, 02181, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Duluth Minnesota, 55805, United States
Robbinsdale Minnesota, 55422, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63131, United States
Reno Nevada, 89520, United States
East Orange New Jersey, 07018, United States
Bronx New York, 10461, United States
Brooklyn New York, 11212, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Raleigh North Carolina, 27609, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43235, United States
Oklahoma City Oklahoma, 73190, United States
Erie Pennsylvania, 16505, United States
Hershey Pennsylvania, 17033, United States
Pittsburgh Pennsylvania, 15213, United States
Spartanburg South Carolina, 29303, United States
Brentwood Tennessee, 37027, United States
Memphis Tennessee, 38103, United States
Corpus Christi Texas, 78412, United States
Tyler Texas, 75710, United States
Salt Lake City Utah, 84132, United States
Danville Virginia, 24541, United States
Seattle Washington, 98104, United States
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