An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer
A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone
1 other identifier
interventional
N/A
1 country
38
Brief Summary
This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone. The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.
Trial Health
Trial Health Score
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38 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2003
CompletedFirst Posted
Study publicly available on registry
January 17, 2003
CompletedJune 24, 2005
February 1, 2004
January 16, 2003
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- The study physician must assure you have/are:
- Must be a female at least 18 years of age and be using an effective form of birth control.
- A documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks.
- A total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases.
- You must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study.
You may not qualify if:
- The study physician must assure you do not have/are not:
- A change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic).
- Received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period.
- Used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug
- Vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention.
- Evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level \> 10.1 mg/dL.
- Use of any investigational drug within 30 days prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Highlands Oncology Group
Springdale, Arkansas, 72764, United States
Bay Area Cancer Research Group
Concord, California, 94520, United States
California Cancer Care, Inc.
Greenbrae, California, 94904, United States
Institute of Cancer Therapies
Los Angeles, California, United States
San Diego Cancer Research Institute
Vista, California, 92083, United States
Anschutz Cancer Pavilion at the University of Colorado Cancer Center
Aurora, Colorado, 80010-0510, United States
Yale University
New Haven, Connecticut, 06520-8028, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Rush Cancer Institute
Chicago, Illinois, 60612-3824, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0098, United States
Louisiana State University
New Orleans, Louisiana, 70112-2278, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, 02115, United States
Josephine Ford Cancer Center
Detroit, Michigan, 48202, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Southfield Oncology Institute, Inc.
Southfield, Michigan, 48076, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
HemOnCare, P.C.
Brooklyn, New York, 11235, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
SUNY Upstate Medical University
Syracuse, New York, 12310, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Ireland Cancer Center
Cleveland, Ohio, 44106, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Palmetto Health
Columbia, South Carolina, 29203, United States
Boston Baskin Cancer Group
Memphis, Tennessee, 38104, United States
The Boston Baskin Cancer Group
Memphis, Tennessee, 38104, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Cancer Specialists of South Texas, PA
Corpus Christi, Texas, 78412, United States
Center for Oncology Research & Treatment
Dallas, Texas, 75230, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 16, 2003
First Posted
January 17, 2003
Last Updated
June 24, 2005
Record last verified: 2004-02