Back to resultsZoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
Primary Purpose
Hypercalcemia of Malignancy, Lung Cancer, Metastatic Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
zoledronic acid
quality-of-life assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Hypercalcemia of Malignancy focused on measuring hypercalcemia of malignancy, pain, recurrent non-small cell lung cancer, recurrent small cell lung cancer, unspecified adult solid tumor, protocol specific, bone metastases
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)
Sites / Locations
- SORRA Research Center
- Brookwood ACCC
- University of Alabama Comprehensive Cancer Center
- Highlands Oncology Group
- Columbia South Valley Hospital
- Pacific Shores Medical Group
- Veterans Affairs Medical Center - West Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Southwest Cancer Care
- Cancer and Blood Institute of the Desert
- Oncology Clinic, P.C.
- Veterans Affairs Medical Center - Denver
- Vincent T. Lombardi Cancer Research Center, Georgetown University
- Veterans Affairs Medical Center - Miami
- Oncology-Hematology Group of South Florida
- H. Lee Moffitt Cancer Center and Research Institute
- American Medical Research Institute, Inc.
- Oncology Care Center - Belleville
- Fort Wayne Medical Oncology and Hematology, Inc.
- University of Iowa Hospitals and Clinics
- Louisiana State University Medical Center
- Ochsner Clinic
- Louisiana State University Health Sciences Center - Shreveport
- Maine Center for Cancer Medicine and Blood Disorders
- Greater Baltimore Medical Center and Cancer Center
- New England Medical Center Hospital
- New England Hematology/Oncology Associates, P.C.
- Henry Ford Hospital
- Spectrum Health and DeVos Children's Hospital
- St. Mary's/Duluth Clinic Health System
- Hubert H. Humphrey Cancer Center
- Kansas City Internal Medicine
- Missouri Baptist Cancer Center
- Veterans Affairs Medical Center - Reno
- Veterans Affairs Medical Center - East Orange
- Albert Einstein Comprehensive Cancer Center
- Brookdale University Hospital and Medical Center
- North Shore University Hospital
- New York Presbyterian Hospital - Cornell Campus
- University of Rochester Cancer Center
- Raleigh Internal Medicine
- Cleveland Clinic Cancer Center
- Hematology Oncology Consultants Inc
- University of Oklahoma College of Medicine
- Regional Cancer Center - Erie
- Milton S. Hershey Medical Center
- University of Pittsburgh Cancer Institute
- Palmetto Hematology/Oncology Associates
- Dial Research Associates
- Methodist Hospitals of Memphis
- Cancer Specialist of South Texas. P.A.
- University of Texas Health Center at Tyler
- Huntsman Cancer Institute
- Danville Hematology and Oncology, Inc.
- Swedish Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00003884
Brief Title
Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
January 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercalcemia of Malignancy, Lung Cancer, Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
hypercalcemia of malignancy, pain, recurrent non-small cell lung cancer, recurrent small cell lung cancer, unspecified adult solid tumor, protocol specific, bone metastases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knight, MD
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
SORRA Research Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35203
Country
United States
Facility Name
Brookwood ACCC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Columbia South Valley Hospital
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Veterans Affairs Medical Center - West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Southwest Cancer Care
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Cancer and Blood Institute of the Desert
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Oncology Clinic, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Veterans Affairs Medical Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Vincent T. Lombardi Cancer Research Center, Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Veterans Affairs Medical Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Oncology-Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
American Medical Research Institute, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Oncology Care Center - Belleville
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Louisiana State University Medical Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70502-4016
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Greater Baltimore Medical Center and Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
New England Hematology/Oncology Associates, P.C.
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02181
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum Health and DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
St. Mary's/Duluth Clinic Health System
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Kansas City Internal Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Veterans Affairs Medical Center - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89520
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018-1095
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Brookdale University Hospital and Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Raleigh Internal Medicine
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Cleveland Clinic Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hematology Oncology Consultants Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Regional Cancer Center - Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Palmetto Hematology/Oncology Associates
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Dial Research Associates
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Methodist Hospitals of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Cancer Specialist of South Texas. P.A.
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75710
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Danville Hematology and Oncology, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
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