Non-Small-Cell Lung Cancer Clinical Trial
Official title:
A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis
| Verified date | November 2009 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | November 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Cancer Outreach | Abingdon | Virginia |
| United States | Summa Health System | Akron | Ohio |
| United States | Cabrini Center for Cancer Care | Alexandria | Louisiana |
| United States | Pacific Cancer Medical Center Inc. | Anaheim | California |
| United States | Hematology & Oncology of N.E. GA | Athens | Georgia |
| United States | Augusta Onc. Associates | Augusta | Georgia |
| United States | Southwest Regional Cancer Center | Austin | Texas |
| United States | Maryland Hematology/Oncology Associates | Baltimore | Maryland |
| United States | Sinai Hospital | Baltimore | Maryland |
| United States | Oncology-Hematology of Lehigh Valley PC | Bethlehem | Pennsylvania |
| United States | Birmingham Hematology and Oncology Associates | Birmingham | Alabama |
| United States | St. Joseph Regional Cancer Ctr. | Bryan | Texas |
| United States | Alamance Regional Medical Ctr. Cancer Ctr. | Burlington | North Carolina |
| United States | Sierra Nevada Oncology Care | Carson City | Nevada |
| United States | Associates in Oncology and Hematology | Chattanooga | Tennessee |
| United States | Center For Cancer & Hematologic Disease | Cherry Hill | New Jersey |
| United States | David H. Smith, MD | Chestertown | Maryland |
| United States | OHCI | Cincinnati | Ohio |
| United States | Oncology-Hematology Associates, PA | Clinton | Maryland |
| United States | The Family Cancer Center, PLLC | Collierville | Tennessee |
| United States | Maryland Oncology | Columbia | Maryland |
| United States | South Carolina Oncology Assoc., PA | Columbia | South Carolina |
| United States | Bay Area Cancer Research Group | Concord | California |
| United States | Coastal Bend Cancer Center | Corpus Christi | Texas |
| United States | Center for Oncology Research and Treatment, PA | Dallas | Texas |
| United States | Regional Cancer Center | Danville | Illinois |
| United States | Rocky Mountain Cancer Centers | Denver | Colorado |
| United States | Henry Ford Medical Center | Detroit | Michigan |
| United States | Hematology-Oncology Associates of CNY | East Syracuse | New York |
| United States | The Cancer Institute at Alexian Brothers | Elk Grove Village | Illinois |
| United States | Western WA Med. Grp. Oncology | Everett | Washington |
| United States | Singh & Arora Hematology/Oncology | Flint | Michigan |
| United States | Lekha Babu M.D Ltd. | Flossmoor | Illinois |
| United States | Front Range Cancer Specialists | Fort Collins | Colorado |
| United States | Hembree Cancer Center-St. Edward Mercy Medical Center | Fort Smith | Arkansas |
| United States | Fresno Hem/Onc Medical Group | Fresno | California |
| United States | Gainesville Hematology Oncology Associates | Gainesville | Florida |
| United States | Oncology Alliance, S.C. | Glendale | Wisconsin |
| United States | Greeley Medical Clinic | Greeley | Colorado |
| United States | Beaver Med Group | Highland | California |
| United States | Oncology Consultants P.A. | Houston | Texas |
| United States | Huntington Medical Group | Huntington Station | New York |
| United States | Baptist Cancer Institute | Jacksonville | Florida |
| United States | Broome Oncology | Johnson City | New York |
| United States | McLeod Cancer & Blood Center | Johnson City | Tennessee |
| United States | Paul V. Woolley MD PC | Johnstown | Pennsylvania |
| United States | Joliet Oncology Hematology Associates, Ltd | Joliet | Illinois |
| United States | Heartland Hematology/Oncology Associates Inc. | Kansas City | Missouri |
| United States | Kingsport Hematology-Oncology | Kingsport | Tennessee |
| United States | Western Washington Oncology | Lacey | Washington |
| United States | Louisiana Oncology Associates | Lafayette | Louisiana |
| United States | LaGrange Oncology Associates | LaGrange | Illinois |
| United States | Center for Cancer Care & Research | Lakeland | Florida |
| United States | Western Hematology/Oncology | Lakewood | Colorado |
| United States | Nevada Cancer Center | Las Vegas | Nevada |
| United States | US Oncology | Las Vegas | Nevada |
| United States | Lake Heart & Cancer Center | Leesburg | Florida |
| United States | Kentuckiana Cancer Center, PLLC | Louisville | Kentucky |
| United States | Lynchburg Oncology | Lynchburg | Virginia |
| United States | Mukesh Bhatt, MD | Medina | Ohio |
| United States | Melbourne Internal Medicine Assoc (MIMA) Century Research | Melbourne | Florida |
| United States | Eastern Connecticut Hematology/Oncology | Memphis | Tennessee |
| United States | Oncology Hematology of South Florida | Memphis | Tennessee |
| United States | The West Clinic | Memphis | Tennessee |
| United States | Hematology and Oncology Specialists | Metairie | Louisiana |
| United States | Caritas Holy Family Hospital | Methuen | Massachusetts |
| United States | HOANNJ/Carol G. Simon Cancer Center | Morristown | New Jersey |
| United States | Medical Consultants, PC | Muncie | Indiana |
| United States | Pasco Pinellas Cancer Center | New Port Richey | Florida |
| United States | Kin Yui Lam, MD | New York | New York |
| United States | Christiana Care Health Services | Newark | Delaware |
| United States | Northwest Medical Specialists | Niles | Illinois |
| United States | Ocala Oncology Center | Ocala | Florida |
| United States | M. Farouk Kanaa, MD, Inc. | Oklahoma City | Oklahoma |
| United States | Mid- Florida Hematology & Oncology Centers, PA | Orange City | Florida |
| United States | W. Kentucky Hematology's Oncology Group, PSC | Paducah | Kentucky |
| United States | Raleigh Hematology Oncology Associates | Raleigh | North Carolina |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Oncology/Hematology Association of SW VA | Roanoke | Virginia |
| United States | Hubert Humphrey Cancer Center | Robbinsdale | Minnesota |
| United States | South Texas Oncology & Hematology | San Antonio | Texas |
| United States | Redwood Regional Medical Group | Santa Rosa | California |
| United States | Swedish Health Services | Seattle | Washington |
| United States | Highland Clinic, APMC | Shreveport | Louisiana |
| United States | Midwest Cancer Research Group | Skokie | Illinois |
| United States | Suburban Hematology-Oncology | Snellville | Georgia |
| United States | Medical Hematology/Oncology | Somerset | New Jersey |
| United States | Palmetto Hematology Oncology, P.C | Spartanburg | South Carolina |
| United States | St. Joseph Onocology, Inc. | St. Joseph | Missouri |
| United States | St. John's Mercy Medical Center | St. Louis | Missouri |
| United States | University Hematology Oncology, Inc. | St. Louis | Missouri |
| United States | Hematology Oncology PC | Stamford | Connecticut |
| United States | Stockton Hem. Onc. | Stockton | California |
| United States | Space Coast Medical | Titusville | Florida |
| United States | St. Joseph Medical Center | Towson | Maryland |
| United States | Cancer Treatment Center | Tulsa | Oklahoma |
| United States | Tyler Cancer Center | Tyler | Texas |
| United States | Vero Beach Hematology/Oncology | Vero Beach | Florida |
| United States | Chester County Hematology/Oncology Services | West Chester | Pennsylvania |
| United States | Lawrence M. Stallings, MD, LLC | Wooster | Ohio |
| United States | Fallon Clinic | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases | |||
| Primary | Group 2: Observational | |||
| Secondary | Patients with an SRE will be evaluated for: | |||
| Secondary | Time from stage IIIB/IV NSCLC diagnosis to progression to bone | |||
| Secondary | Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications | |||
| Secondary | The effect of serum NTX levels on the development of skeletal events (SREs), and | |||
| Secondary | Overall survival | |||
| Secondary | Group 2: Obervational |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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