Hypercalcemia of MalignancyPhase 3NCT00003884
Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
A Phase 3 study testing zoledronic acid and quality-of-life assessment in people with Hypercalcemia of Malignancy and Lung Cancer, run by Novartis at 55 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercalcemia of Malignancy, Lung Cancer, Metastatic Cancer
- What is being tested?
- zoledronic acid and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 55 sitesUnited States
- Study dates
- Aug 1998to Jan 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
American Medical Research Institute, Inc.
Atlanta, Georgia, 30338
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
Oncology Care Center - Belleville
Belleville, Illinois, 62226
SORRA Research Center
Birmingham, Alabama, 35203
Brookwood ACCC
Birmingham, Alabama, 35209
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
New England Medical Center Hospital
Boston, Massachusetts, 02111
Dial Research Associates
Brentwood, Tennessee, 37027
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
Oncology Clinic, P.C.
Colorado Springs, Colorado, 80909
Hematology Oncology Consultants Inc
Columbus, Ohio, 43235
Cancer Specialist of South Texas. P.A.
Corpus Christi, Texas, 78412
Danville Hematology and Oncology, Inc.
Danville, Virginia, 24541
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
Henry Ford Hospital
Detroit, Michigan, 48202
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
Regional Cancer Center - Erie
Erie, Pennsylvania, 16505
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46885-5099
Columbia South Valley Hospital
Gilroy, California, 95020
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Kansas City Internal Medicine
Kansas City, Missouri, 64132
Louisiana State University Medical Center
Lafayette, Louisiana, 70502-4016
Pacific Shores Medical Group
Long Beach, California, 90813
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
North Shore University Hospital
Manhasset, New York, 11030
Methodist Hospitals of Memphis
Memphis, Tennessee, 38103
Veterans Affairs Medical Center - Miami
Miami, Florida, 33125
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
Ochsner Clinic
New Orleans, Louisiana, 70121
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
Southwest Cancer Care
Poway, California, 92064
Raleigh Internal Medicine
Raleigh, North Carolina, 27609
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
Veterans Affairs Medical Center - Reno
Reno, Nevada, 89520
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422
University of Rochester Cancer Center
Rochester, New York, 14642
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
Swedish Cancer Institute
Seattle, Washington, 98104
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, 29303
Highlands Oncology Group
Springdale, Arkansas, 72764
Missouri Baptist Cancer Center
St Louis, Missouri, 63131
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
University of Texas Health Center at Tyler
Tyler, Texas, 75710
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, 20007
New England Hematology/Oncology Associates, P.C.
Wellesley, Massachusetts, 02181
About this study
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
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.
Read the 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.
- Conditions
- Hypercalcemia of Malignancy, Lung Cancer, Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- zoledronic acid, quality-of-life assessment
- Keywords
- hypercalcemia of malignancy, pain, recurrent non-small cell lung cancer, recurrent small cell lung cancer, unspecified adult solid tumor, protocol specific, bone metastases
- Medical subject headings
- Humoral Hypercalcemia Of Malignancy, Lung Neoplasms, Neoplasm Metastasis, Pain, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2004 (estimated)
- Study startAug 1998
- Primary completionJan 2001
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercalcemia of MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Knight, MD, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003884
- Sponsor's protocol ID
- CDR0000067052
- Other IDs
- NOVARTIS-4244603011
- Status last verified
- Feb 2013
- First submitted
- 1 Nov 1999
- Last updated
- 21 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00003884
- Acronym / sponsor ID
- CDR0000067052
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jan 2001 (actual)
- First posted
- 22 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zoledronic acid | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Knight, MD study chair
Novartis Pharmaceuticals
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zoledronic acid and quality-of-life assessment in people with Hypercalcemia of Malignancy and Lung Cancer, run by Novartis at 55 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.