Non-small Cell Lung Cancer Registry
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099541
First received: December 15, 2004
Last updated: November 20, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Cancer Pleural Effusion, Malignant |
Drug: zoledronic acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
- Group 2: Observational
Secondary Outcome Measures:
- Patients with an SRE will be evaluated for:
- Time from stage IIIB/IV NSCLC diagnosis to progression to bone
- Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
- The effect of serum NTX levels on the development of skeletal events (SREs), and
- Overall survival
- Group 2: Obervational
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | November 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099541
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| United States, Alabama | |
| Birmingham Hematology and Oncology Associates | |
| Birmingham, Alabama, United States, 35205 | |
| United States, Arkansas | |
| Hembree Cancer Center-St. Edward Mercy Medical Center | |
| Fort Smith, Arkansas, United States, 72903 | |
| United States, California | |
| Pacific Cancer Medical Center Inc. | |
| Anaheim, California, United States, 92801 | |
| Bay Area Cancer Research Group | |
| Concord, California, United States, 94520 | |
| Fresno Hem/Onc Medical Group | |
| Fresno, California, United States, 93720 | |
| Beaver Med Group | |
| Highland, California, United States, 92346 | |
| Redwood Regional Medical Group | |
| Santa Rosa, California, United States, 95403 | |
| Stockton Hem. Onc. | |
| Stockton, California, United States, 95204 | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers | |
| Denver, Colorado, United States, 80218 | |
| Front Range Cancer Specialists | |
| Fort Collins, Colorado, United States, 80524 | |
| Greeley Medical Clinic | |
| Greeley, Colorado, United States, 80631 | |
| Western Hematology/Oncology | |
| Lakewood, Colorado, United States, 80215 | |
| United States, Connecticut | |
| Hematology Oncology PC | |
| Stamford, Connecticut, United States, 06902 | |
| United States, Delaware | |
| Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Gainesville Hematology Oncology Associates | |
| Gainesville, Florida, United States, 32605 | |
| Baptist Cancer Institute | |
| Jacksonville, Florida, United States, 32207 | |
| Center for Cancer Care & Research | |
| Lakeland, Florida, United States, 33805 | |
| Lake Heart & Cancer Center | |
| Leesburg, Florida, United States, 34748 | |
| Melbourne Internal Medicine Assoc (MIMA) Century Research | |
| Melbourne, Florida, United States, 32901 | |
| Pasco Pinellas Cancer Center | |
| New Port Richey, Florida, United States, 34652 | |
| Ocala Oncology Center | |
| Ocala, Florida, United States, 34474 | |
| Mid- Florida Hematology & Oncology Centers, PA | |
| Orange City, Florida, United States, 32763 | |
| Space Coast Medical | |
| Titusville, Florida, United States, 32796 | |
| Vero Beach Hematology/Oncology | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Georgia | |
| Hematology & Oncology of N.E. GA | |
| Athens, Georgia, United States, 30607 | |
| Augusta Onc. Associates | |
| Augusta, Georgia, United States, 30901 | |
| Suburban Hematology-Oncology | |
| Snellville, Georgia, United States, 30078 | |
| United States, Illinois | |
| Regional Cancer Center | |
| Danville, Illinois, United States, 61832 | |
| The Cancer Institute at Alexian Brothers | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Lekha Babu M.D Ltd. | |
| Flossmoor, Illinois, United States, 60422 | |
| Joliet Oncology Hematology Associates, Ltd | |
| Joliet, Illinois, United States, 60435 | |
| LaGrange Oncology Associates | |
| LaGrange, Illinois, United States, 60525 | |
| Northwest Medical Specialists | |
| Niles, Illinois, United States, 60714 | |
| Midwest Cancer Research Group | |
| Skokie, Illinois, United States, 60077 | |
| United States, Indiana | |
| Medical Consultants, PC | |
| Muncie, Indiana, United States, 47303 | |
| United States, Kentucky | |
| Kentuckiana Cancer Center, PLLC | |
| Louisville, Kentucky, United States, 40202 | |
| W. Kentucky Hematology's Oncology Group, PSC | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Louisiana | |
| Cabrini Center for Cancer Care | |
| Alexandria, Louisiana, United States, 71301 | |
| Louisiana Oncology Associates | |
| Lafayette, Louisiana, United States, 70506 | |
| Hematology and Oncology Specialists | |
| Metairie, Louisiana, United States, 70006 | |
| Highland Clinic, APMC | |
| Shreveport, Louisiana, United States, 71105 | |
| United States, Maryland | |
| Maryland Hematology/Oncology Associates | |
| Baltimore, Maryland, United States, 21237 | |
| Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| David H. Smith, MD | |
| Chestertown, Maryland, United States, 21620 | |
| Oncology-Hematology Associates, PA | |
| Clinton, Maryland, United States, 20735 | |
| Maryland Oncology | |
| Columbia, Maryland, United States, 21044 | |
| St. Joseph Medical Center | |
| Towson, Maryland, United States, 21204 | |
| United States, Massachusetts | |
| Caritas Holy Family Hospital | |
| Methuen, Massachusetts, United States, 01844 | |
| Fallon Clinic | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| Henry Ford Medical Center | |
| Detroit, Michigan, United States, 48202 | |
| Singh & Arora Hematology/Oncology | |
| Flint, Michigan, United States, 48532 | |
| United States, Minnesota | |
| Hubert Humphrey Cancer Center | |
| Robbinsdale, Minnesota, United States, 55442 | |
| United States, Missouri | |
| Heartland Hematology/Oncology Associates Inc. | |
| Kansas City, Missouri, United States, 64118 | |
| St. Joseph Onocology, Inc. | |
| St. Joseph, Missouri, United States, 64507 | |
| St. John's Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| University Hematology Oncology, Inc. | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Sierra Nevada Oncology Care | |
| Carson City, Nevada, United States, 89703 | |
| US Oncology | |
| Las Vegas, Nevada, United States, 89109 | |
| Nevada Cancer Center | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Center For Cancer & Hematologic Disease | |
| Cherry Hill, New Jersey, United States, 08003 | |
| HOANNJ/Carol G. Simon Cancer Center | |
| Morristown, New Jersey, United States, 07960 | |
| Medical Hematology/Oncology | |
| Somerset, New Jersey, United States, 08873 | |
| United States, New York | |
| Hematology-Oncology Associates of CNY | |
| East Syracuse, New York, United States, 13057 | |
| Huntington Medical Group | |
| Huntington Station, New York, United States, 11746 | |
| Broome Oncology | |
| Johnson City, New York, United States, 13790 | |
| Kin Yui Lam, MD | |
| New York, New York, United States, 10013 | |
| United States, North Carolina | |
| Alamance Regional Medical Ctr. Cancer Ctr. | |
| Burlington, North Carolina, United States, 27215 | |
| Raleigh Hematology Oncology Associates | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Summa Health System | |
| Akron, Ohio, United States, 44304 | |
| OHCI | |
| Cincinnati, Ohio, United States, 45242 | |
| Mukesh Bhatt, MD | |
| Medina, Ohio, United States, 44256 | |
| Lawrence M. Stallings, MD, LLC | |
| Wooster, Ohio, United States, 44691 | |
| United States, Oklahoma | |
| M. Farouk Kanaa, MD, Inc. | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Cancer Treatment Center | |
| Tulsa, Oklahoma, United States, 74133 | |
| United States, Pennsylvania | |
| Oncology-Hematology of Lehigh Valley PC | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Paul V. Woolley MD PC | |
| Johnstown, Pennsylvania, United States, 15905 | |
| Chester County Hematology/Oncology Services | |
| West Chester, Pennsylvania, United States, 19380 | |
| United States, South Carolina | |
| South Carolina Oncology Assoc., PA | |
| Columbia, South Carolina, United States, 29201 | |
| Palmetto Hematology Oncology, P.C | |
| Spartanburg, South Carolina, United States, 29303-3041 | |
| United States, Tennessee | |
| Associates in Oncology and Hematology | |
| Chattanooga, Tennessee, United States, 37404 | |
| The Family Cancer Center, PLLC | |
| Collierville, Tennessee, United States, 38017 | |
| McLeod Cancer & Blood Center | |
| Johnson City, Tennessee, United States, 37604 | |
| Kingsport Hematology-Oncology | |
| Kingsport, Tennessee, United States, 37660 | |
| Eastern Connecticut Hematology/Oncology | |
| Memphis, Tennessee, United States, 38138 | |
| Oncology Hematology of South Florida | |
| Memphis, Tennessee, United States, 38138 | |
| The West Clinic | |
| Memphis, Tennessee, United States, 38138 | |
| United States, Texas | |
| Southwest Regional Cancer Center | |
| Austin, Texas, United States, 78705 | |
| St. Joseph Regional Cancer Ctr. | |
| Bryan, Texas, United States, 77802 | |
| Coastal Bend Cancer Center | |
| Corpus Christi, Texas, United States, 78404 | |
| Center for Oncology Research and Treatment, PA | |
| Dallas, Texas, United States, 75230 | |
| Oncology Consultants P.A. | |
| Houston, Texas, United States, 77024 | |
| South Texas Oncology & Hematology | |
| San Antonio, Texas, United States, 78258 | |
| Tyler Cancer Center | |
| Tyler, Texas, United States, 75702 | |
| United States, Virginia | |
| Cancer Outreach | |
| Abingdon, Virginia, United States, 24211 | |
| Lynchburg Oncology | |
| Lynchburg, Virginia, United States, 24501 | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
| Oncology/Hematology Association of SW VA | |
| Roanoke, Virginia, United States, 24104 | |
| United States, Washington | |
| Western WA Med. Grp. Oncology | |
| Everett, Washington, United States, 98201 | |
| Western Washington Oncology | |
| Lacey, Washington, United States, 98503 | |
| Swedish Health Services | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Oncology Alliance, S.C. | |
| Glendale, Wisconsin, United States, 53212 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Chair: | L. Lacerna, MD | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00099541 History of Changes |
| Other Study ID Numbers: | CZOL446EUS99, US99, Z-NEXT |
| Study First Received: | December 15, 2004 |
| Last Updated: | November 20, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Novartis:
|
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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Pleural Effusion Pleural Effusion, Malignant Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Pleural Diseases Pleural Neoplasms Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013