Clinical trial NCT00099541: Non-small Cell Lung Cancer Registry
Official title: A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Small-Cell Lung Cancer
Pleural Effusion, Malignant
Keywords: Lung Cancer
Bone Metastases
Bone Markers
NTX
zoledronic acid
Registry
Unresectable Stage IV Non Small-cell Lung Cancer (NSCLC)
Unresectable Stage IIIB NSCLC with Pleural Effusion
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma).
* Unresectable Stage IIIB with pleural effusion or stage IV NSCLC
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid)
* Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)
* Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys
* Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate)
* Abnormal renal function or creatinine clearance
* Unstable brain metastasis
* Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding
* Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol

Primary outcomes:
measure: Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
measure: Group 2: Observational
Secondary outcomes:
measure: Patients with an SRE will be evaluated for:
measure: Time from stage IIIB/IV NSCLC diagnosis to progression to bone
measure: Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
measure: The effect of serum NTX levels on the development of skeletal events (SREs), and
measure: Overall survival
measure: Group 2: Obervational
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates
state: Alabama
city: Fort Smith
country: United States
facility: Hembree Cancer Center-St. Edward Mercy Medical Center
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center Inc.
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Fresno
country: United States
facility: Fresno Hem/Onc Medical Group
state: California
city: Highland
country: United States
facility: Beaver Med Group
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group
state: California
city: Stockton
country: United States
facility: Stockton Hem. Onc.
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Fort Collins
country: United States
facility: Front Range Cancer Specialists
state: Colorado
city: Greeley
country: United States
facility: Greeley Medical Clinic
state: Colorado
city: Lakewood
country: United States
facility: Western Hematology/Oncology
state: Colorado
city: Stamford
country: United States
facility: Hematology Oncology PC
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Gainesville
country: United States
facility: Gainesville Hematology Oncology Associates
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Lakeland
country: United States
facility: Center for Cancer Care & Research
state: Florida
city: Leesburg
country: United States
facility: Lake Heart & Cancer Center
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Assoc (MIMA) Century Research
state: Florida
city: New Port Richey
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orange City
country: United States
facility: Mid- Florida Hematology & Oncology Centers, PA
state: Florida
city: Titusville
country: United States
facility: Space Coast Medical
state: Florida
city: Vero Beach
country: United States
facility: Vero Beach Hematology/Oncology
state: Florida
city: Athens
country: United States
facility: Hematology & Oncology of N.E. GA
state: Georgia
city: Augusta
country: United States
facility: Augusta Onc. Associates
state: Georgia
city: Snellville
country: United States
facility: Suburban Hematology-Oncology
state: Georgia
city: Danville
country: United States
facility: Regional Cancer Center
state: Illinois
city: Elk Grove Village
country: United States
facility: The Cancer Institute at Alexian Brothers
state: Illinois
city: Flossmoor
country: United States
facility: Lekha Babu M.D Ltd.
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Associates, Ltd
state: Illinois
city: LaGrange
country: United States
facility: LaGrange Oncology Associates
state: Illinois
city: Niles
country: United States
facility: Northwest Medical Specialists
state: Illinois
city: Skokie
country: United States
facility: Midwest Cancer Research Group
state: Illinois
city: Muncie
country: United States
facility: Medical Consultants, PC
state: Indiana
city: Louisville
country: United States
facility: Kentuckiana Cancer Center, PLLC
state: Kentucky
city: Paducah
country: United States
facility: W. Kentucky Hematology's Oncology Group, PSC
state: Kentucky
city: Alexandria
country: United States
facility: Cabrini Center for Cancer Care
state: Louisiana
city: Lafayette
country: United States
facility: Louisiana Oncology Associates
state: Louisiana
city: Metairie
country: United States
facility: Hematology and Oncology Specialists
state: Louisiana
city: Shreveport
country: United States
facility: Highland Clinic, APMC
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital
state: Maryland
city: Baltimore
country: United States
facility: Maryland Hematology/Oncology Associates
state: Maryland
city: Chestertown
country: United States
facility: David H. Smith, MD
state: Maryland
city: Clinton
country: United States
facility: Oncology-Hematology Associates, PA
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology
state: Maryland
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Methuen
country: United States
facility: Caritas Holy Family Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Flint
country: United States
facility: Singh & Arora Hematology/Oncology
state: Michigan
city: Robbinsdale
country: United States
facility: Hubert Humphrey Cancer Center
state: Minnesota
city: Kansas City
country: United States
facility: Heartland Hematology/Oncology Associates Inc.
state: Missouri
city: St. Joseph
country: United States
facility: St. Joseph Onocology, Inc.
state: Missouri
city: St. Louis
country: United States
facility: University Hematology Oncology, Inc.
state: Missouri
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Carson City
country: United States
facility: Sierra Nevada Oncology Care
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: Las Vegas
country: United States
facility: US Oncology
state: Nevada
city: Cherry Hill
country: United States
facility: Center For Cancer & Hematologic Disease
state: New Jersey
city: Morristown
country: United States
facility: HOANNJ/Carol G. Simon Cancer Center
state: New Jersey
city: Somerset
country: United States
facility: Medical Hematology/Oncology
state: New Jersey
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of CNY
state: New York
city: Huntington Station
country: United States
facility: Huntington Medical Group
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: New York
country: United States
facility: Kin Yui Lam, MD
state: New York
city: Burlington
country: United States
facility: Alamance Regional Medical Ctr. Cancer Ctr.
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: OHCI
state: Ohio
city: Medina
country: United States
facility: Mukesh Bhatt, MD
state: Ohio
city: Wooster
country: United States
facility: Lawrence M. Stallings, MD, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: M. Farouk Kanaa, MD, Inc.
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Treatment Center
state: Oklahoma
city: Bethlehem
country: United States
facility: Oncology-Hematology of Lehigh Valley PC
state: Pennsylvania
city: Johnstown
country: United States
facility: Paul V. Woolley MD PC
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hematology/Oncology Services
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Assoc., PA
state: South Carolina
city: Spartanburg
country: United States
facility: Palmetto Hematology Oncology, P.C
state: South Carolina
city: Chattanooga
country: United States
facility: Associates in Oncology and Hematology
state: Tennessee
city: Collierville
country: United States
facility: The Family Cancer Center, PLLC
state: Tennessee
city: Johnson City
country: United States
facility: McLeod Cancer & Blood Center
state: Tennessee
city: Kingsport
country: United States
facility: Kingsport Hematology-Oncology
state: Tennessee
city: Memphis
country: United States
facility: Eastern Connecticut Hematology/Oncology
state: Tennessee
city: Memphis
country: United States
facility: Oncology Hematology of South Florida
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Bryan
country: United States
facility: St. Joseph Regional Cancer Ctr.
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment, PA
state: Texas
city: Houston
country: United States
facility: Oncology Consultants P.A.
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology & Hematology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Abingdon
country: United States
facility: Cancer Outreach
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Oncology
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Oncology/Hematology Association of SW VA
state: Virginia
city: Everett
country: United States
facility: Western WA Med. Grp. Oncology
state: Washington
city: Lacey
country: United States
facility: Western Washington Oncology
state: Washington
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
city: Glendale
country: United States
facility: Oncology Alliance, S.C.
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: L. Lacerna, MD
role: STUDY_CHAIR
References: