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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

Phase 3
18 Years
Not Enrolling
Hypercalcemia of Malignancy, Lung Cancer, Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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

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.

Inclusion 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)

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

January 2001

Related Keywords:

  • Hypercalcemia of Malignancy
  • Lung Cancer
  • Metastatic Cancer
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • hypercalcemia of malignancy
  • pain
  • recurrent non-small cell lung cancer
  • recurrent small cell lung cancer
  • unspecified adult solid tumor, protocol specific
  • bone metastases
  • Neoplasms
  • Hypercalcemia
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Rochester Cancer Center Rochester, New York  14642
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
New England Medical Center Hospital Boston, Massachusetts  02111
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Greater Baltimore Medical Center and Cancer Center Baltimore, Maryland  21204
Swedish Cancer Institute Seattle, Washington  98104
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - West Los Angeles Los Angeles, California  90073
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
University of Texas Health Center at Tyler Tyler, Texas  75708
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Ochsner Clinic New Orleans, Louisiana  70121
Spectrum Health and DeVos Children's Hospital Grand Rapids, Michigan  49503
Brookdale University Hospital and Medical Center Brooklyn, New York  11212
Hematology Oncology Consultants Inc Columbus, Ohio  43235
St. Mary's/Duluth Clinic Health System Duluth, Minnesota  55805
Oncology-Hematology Group of South Florida Miami, Florida  33176
Hubert H. Humphrey Cancer Center Coon Rapids, Minnesota  55433
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana  46885-5099
Palmetto Hematology/Oncology Associates Spartanburg, South Carolina  29303
Maine Center for Cancer Medicine and Blood Disorders Scarborough, Maine  04074
Kansas City Internal Medicine Kansas City, Missouri  64132
Danville Hematology and Oncology, Inc. Danville, Virginia  24541
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer and Blood Institute of the Desert Rancho Mirage, California  92270
Pacific Shores Medical Group Long Beach, California  90813
Brookwood ACCC Birmingham, Alabama  35209
SORRA Research Center Birmingham, Alabama  35203
Highlands Oncology Group Springdale, Arkansas  72764
Columbia South Valley Hospital Gilroy, California  95020
Southwest Cancer Care Poway, California  92064
Oncology Clinic, P.C. Colorado Springs, Colorado  80909
American Medical Research Institute, Inc. Atlanta, Georgia  30338
Oncology Care Center - Belleville Belleville, Illinois  62226
Louisiana State University Medical Center Lafayette, Louisiana  70502-4016
New England Hematology/Oncology Associates, P.C. Wellesley, Massachusetts  02181
Veterans Affairs Medical Center - Reno Reno, Nevada  89520
Raleigh Internal Medicine Raleigh, North Carolina  27609
Regional Cancer Center - Erie Erie, Pennsylvania  16505
Dial Research Associates Brentwood, Tennessee  37027
Methodist Hospitals of Memphis Memphis, Tennessee  38103
Cancer Specialist of South Texas. P.A. Corpus Christi, Texas  78412