Pain Clinical Trial
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
Verified date | February 2013 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | January 2001 |
Est. primary completion date | January 2001 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | American Medical Research Institute, Inc. | Atlanta | Georgia |
United States | Greater Baltimore Medical Center and Cancer Center | Baltimore | Maryland |
United States | Oncology Care Center - Belleville | Belleville | Illinois |
United States | Brookwood ACCC | Birmingham | Alabama |
United States | SORRA Research Center | Birmingham | Alabama |
United States | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama |
United States | New England Medical Center Hospital | Boston | Massachusetts |
United States | Dial Research Associates | Brentwood | Tennessee |
United States | Albert Einstein Comprehensive Cancer Center | Bronx | New York |
United States | Brookdale University Hospital and Medical Center | Brooklyn | New York |
United States | Cleveland Clinic Cancer Center | Cleveland | Ohio |
United States | Oncology Clinic, P.C. | Colorado Springs | Colorado |
United States | Hematology Oncology Consultants Inc | Columbus | Ohio |
United States | Cancer Specialist of South Texas. P.A. | Corpus Christi | Texas |
United States | Danville Hematology and Oncology, Inc. | Danville | Virginia |
United States | Veterans Affairs Medical Center - Denver | Denver | Colorado |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | St. Mary's/Duluth Clinic Health System | Duluth | Minnesota |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | Regional Cancer Center - Erie | Erie | Pennsylvania |
United States | Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana |
United States | Columbia South Valley Hospital | Gilroy | California |
United States | Spectrum Health and DeVos Children's Hospital | Grand Rapids | Michigan |
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Kansas City Internal Medicine | Kansas City | Missouri |
United States | Louisiana State University Medical Center | Lafayette | Louisiana |
United States | Pacific Shores Medical Group | Long Beach | California |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California |
United States | North Shore University Hospital | Manhasset | New York |
United States | Methodist Hospitals of Memphis | Memphis | Tennessee |
United States | Oncology-Hematology Group of South Florida | Miami | Florida |
United States | Veterans Affairs Medical Center - Miami | Miami | Florida |
United States | Ochsner Clinic | New Orleans | Louisiana |
United States | New York Presbyterian Hospital - Cornell Campus | New York | New York |
United States | University of Oklahoma College of Medicine | Oklahoma City | Oklahoma |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
United States | Southwest Cancer Care | Poway | California |
United States | Raleigh Internal Medicine | Raleigh | North Carolina |
United States | Cancer and Blood Institute of the Desert | Rancho Mirage | California |
United States | Veterans Affairs Medical Center - Reno | Reno | Nevada |
United States | Hubert H. Humphrey Cancer Center | Robbinsdale | Minnesota |
United States | University of Rochester Cancer Center | Rochester | New York |
United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Maine Center for Cancer Medicine and Blood Disorders | Scarborough | Maine |
United States | Swedish Cancer Institute | Seattle | Washington |
United States | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana |
United States | Palmetto Hematology/Oncology Associates | Spartanburg | South Carolina |
United States | Highlands Oncology Group | Springdale | Arkansas |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | University of Texas Health Center at Tyler | Tyler | Texas |
United States | Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington | District of Columbia |
United States | New England Hematology/Oncology Associates, P.C. | Wellesley | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States,
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