Clinical trial NCT00051779: An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasms
Breast Cancer
Metastasis
Keywords: CAL
Parathyroid hormone-related protein (PTHrP)
Breast Cancer
Bone Metastasis
Hypercalcemia
Lead sponsor: Chugai Pharma USA
Sponsor class: INDUSTRY
First posted: 2003-01-17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: Major Inclusion Criteria - Others Stipulated within the Protocol

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.

Major Exclusion Criteria - Others Stipulated within the Protocol

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: Los Angeles
country: United States
facility: Institute of Cancer Therapies
state: California
city: Vista
country: United States
facility: San Diego Cancer Research Institute
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion at the University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Ft. Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Chicago
country: United States
facility: Rush Cancer Institute
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Josephine Ford Cancer Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Southfield
country: United States
facility: Southfield Oncology Institute, Inc.
state: Michigan
city: St. Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: HemOnCare, P.C.
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health
state: South Carolina
city: Memphis
country: United States
facility: Boston Baskin Cancer Group
state: Tennessee
city: Memphis
country: United States
facility: The Boston Baskin Cancer Group
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Corpus Christi
country: United States
facility: Cancer Specialists of South Texas, PA
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research & Treatment
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders
state: Wisconsin
Study officials:
References: