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.

Condition	Treatment or Intervention	Phase
Pain bone metastases Recurrent Small Cell Lung Cancer unspecified adult solid tumor, protocol specific recurrent non-small cell lung cancer Quality of Life Hypercalcemia	Drug: zoledronate	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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)

--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

Alabama
      Brookwood ACCC, Birmingham,  Alabama,  35209,  United States
      SORRA Research Center, Birmingham,  Alabama,  35203,  United States
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
Arkansas
      Highlands Oncology Group, Springdale,  Arkansas,  72764,  United States
California
      Cancer and Blood Institute of the Desert, Rancho Mirage,  California,  92270,  United States
      Columbia South Valley Hospital, Gilroy,  California,  95020,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Pacific Shores Medical Group, Long Beach,  California,  90813,  United States
      Southwest Cancer Care, Poway,  California,  92064,  United States
      Veterans Affairs Medical Center - West Los Angeles, Los Angeles,  California,  90073,  United States
Colorado
      Oncology Clinic, P.C., Colorado Springs,  Colorado,  80909,  United States
      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States
District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States
      Oncology-Hematology Group of South Florida, Miami,  Florida,  33176,  United States
      Veterans Affairs Medical Center - Miami, Miami,  Florida,  33125,  United States
Georgia
      American Medical Research Institute, Inc., Atlanta,  Georgia,  30338,  United States
Illinois
      Oncology Care Center - Belleville, Belleville,  Illinois,  62226,  United States
Indiana
      Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne,  Indiana,  46885-5099,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States
      Louisiana State University Medical Center, Lafayette,  Louisiana,  70502-4016,  United States
      Ochsner Clinic, New Orleans,  Louisiana,  70121,  United States
Maine
      Maine Center for Cancer Medicine and Blood Disorders, Scarborough,  Maine,  04074,  United States
Maryland
      Greater Baltimore Medical Center and Cancer Center, Baltimore,  Maryland,  21204,  United States
Massachusetts
      New England Hematology/Oncology Associates, P.C., Wellesley,  Massachusetts,  02181,  United States
      New England Medical Center Hospital, Boston,  Massachusetts,  02111,  United States
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
      Spectrum Health and DeVos Children's Hospital, Grand Rapids,  Michigan,  49503,  United States
Minnesota
      Hubert H. Humphrey Cancer Center, Robbinsdale,  Minnesota,  55422,  United States
      St. Mary's/Duluth Clinic Health System, Duluth,  Minnesota,  55805,  United States
Missouri
      Kansas City Internal Medicine, Kansas City,  Missouri,  64132,  United States
      Missouri Baptist Cancer Center, Saint Louis,  Missouri,  63131,  United States
Nevada
      Veterans Affairs Medical Center - Reno, Reno,  Nevada,  89520,  United States
New Jersey
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      Brookdale University Hospital and Medical Center, Brooklyn,  New York,  11212,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
North Carolina
      Raleigh Internal Medicine, Raleigh,  North Carolina,  27609,  United States
Ohio
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States
      Hematology Oncology Consultants Inc, Columbus,  Ohio,  43235,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
      Regional Cancer Center - Erie, Erie,  Pennsylvania,  16505,  United States
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States
South Carolina
      Palmetto Hematology/Oncology Associates, Spartanburg,  South Carolina,  29303,  United States
Tennessee
      Dial Research Associates, Brentwood,  Tennessee,  37027,  United States
      Methodist Hospitals of Memphis, Memphis,  Tennessee,  38103,  United States
Texas
      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
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84132,  United States
Virginia
      Danville Hematology and Oncology, Inc., Danville,  Virginia,  24541,  United States
Washington
      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States

Study chairs or principal investigators

Robert Knight,  Study Chair,  Novartis Pharmaceuticals   

Study ID Numbers:  CDR0000067052; NOVARTIS-4244603011
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003884
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08