Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Multi-Center Study of the Efficacy of Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) Versus Taxotere (Docetaxel) and Placebo in Non-Small Cell Lung Cancer (NSCLC) Patients After Failure of Prior Platinum-Based Chemotherapy
| Verified date | October 2011 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Taxotere has been approved by the FDA and is considered a standard treatment for patients
with lung cancer who have failed prior platinum-containing regimens. The main purpose of
this research study is to determine if Aptosyn, when given in combination with Taxotere,
will result in prolonged survival when compared to Taxotere alone.
This study will also help determine tumor response rates, and the safety profile of Aptosyn
in combination with Taxotere.
This study has been completed and a publication is pending.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | December 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility | Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas Oncology, PA | Abilene | Texas |
| United States | New York Oncology Hematology | Albany | New York |
| United States | New York Oncology Hematology, PC | Albany | New York |
| United States | Texas Oncology, P.A | Arlington | Texas |
| United States | Asheville Hematology & Oncology Associates, PA | Asheville | North Carolina |
| United States | South Austin Cancer Center | Austin | Texas |
| United States | Mamie McFadden Ward Cancer Center | Beaumont | Texas |
| United States | Texas Oncology, P.A. | Bedford | Texas |
| United States | Hematology Oncology Centers of the Northern Rockies | Billings | Montana |
| United States | Birmingham Hematology and Oncology Associates, LLC | Birmingham | Alabama |
| United States | Birmingham Hematology Oncology Associates | Birmingham | Alabama |
| United States | Boca Raton Comprehensive Cancer Center | Boca Raton | Florida |
| United States | Comprehensive Cancer Care Specialists at Boca Raton | Boca Raton | Florida |
| United States | Rocky Mountain Cancer Center | Boulder | Colorado |
| United States | HemOnCare, PC | Brooklyn | New York |
| United States | Raleigh Hematology Oncology Clini | Cary | North Carolina |
| United States | Iowa Cancer Care, PLC | Cedar Rapids | Iowa |
| United States | Iowa Oncology Associates | Cedar Rapids | Iowa |
| United States | Rocky Mountain Cancer Centers | Colorado Springs | Colorado |
| United States | Central Maryland Oncology Center | Columbia | Maryland |
| United States | Missouri Cancer Associates | Columbia | Missouri |
| United States | Texas Cancer Center at Medical City | Dallas | Texas |
| United States | Texas Onclology, PA | Dallas | Texas |
| United States | Texas Oncology, PA | Dallas | Texas |
| United States | The Texas Cancer Center - Dallas Southwest | Dallas | Texas |
| United States | US Oncology Research | Dallas | Texas |
| United States | Texoma Cancer Center | Denison | Texas |
| United States | RMCC | Denver | Colorado |
| United States | Hematology & Oncolgy Assoc of NE PA | Dunmore | Pennsylvania |
| United States | Regional Hamatology Oncology Associates | Durham | North Carolina |
| United States | North Shore Hematology/Oncology Associates, P.C. | East Setauket | New York |
| United States | Puget Sound Cancer Centers | Edmonds | Washington |
| United States | 12. Rocky Mountain Cancer Centers-Englewood | Englewood | Colorado |
| United States | Rocky Mountain Cancer Centers | Englewood | Colorado |
| United States | Willamette Valley Cancer Center | Eugene | Oregon |
| United States | Evanston Northwestern Healthcare | Evanston | Illinois |
| United States | Fairfax Northern Virginia Hematology-Oncology, PC | Fairfax | Virginia |
| United States | Northern Arizona Hematology and Oncology Associates | Flagstaff | Arizona |
| United States | Rocky Mountain Cancer Centers | Fort Collins | Colorado |
| United States | Texas Oncology, PA | Fort Worth | Texas |
| United States | Pacific Coast Hematology/Oncology Medical Group, Inc. | Fountain Valley | California |
| United States | Impath Predictive Oncology | Franklin | Massachusetts |
| United States | San Antonio Tumor and Blood Clinic | Fredicksburg | Texas |
| United States | Texas Cancer Center | Ft. Worth | Texas |
| United States | Texas Oncology, PA | Garland | Texas |
| United States | Cancer Research of Long Island | Great Neck | New York |
| United States | California Cancer Care, Inc. | Greenbrae | California |
| United States | Cancer Centers of the Carolinas | Greenville | South Carolina |
| United States | Northeastern Carolina Hematology & Oncology, PA | Hickory | North Carolina |
| United States | Texas Oncology, PA | Houston | Texas |
| United States | Texas Oncology, PA | Houston | Texas |
| United States | Texas Oncology, PA | Houston | Texas |
| United States | Texas Oncology, PA | Houston | Texas |
| United States | Central Indiana Cancer Centers | Indianapolis | Indiana |
| United States | Texas Oncology, PA | Irving | Texas |
| United States | Florida Oncology Associates | Jacksonville | Florida |
| United States | North Florida Hematology & Oncology Association | Jacksonville | Florida |
| United States | Kansas City Oncology and Hematology Group | Kansas City | Missouri |
| United States | Dayton Oncology/Hematology, PA | Kettering | Ohio |
| United States | Medical Oncology Associates of Wymoning Valley, PC | Kingston | Pennsylvania |
| United States | South Florida Oncology & Hematology Consultants | Lauderhill | Florida |
| United States | Lake Vista Cancer Center | Lewisville | Texas |
| United States | Arkansas Oncology Associates, PA | Little Rock | Arkansas |
| United States | Rocky Mountain Cancer Centers | Littleton | Colorado |
| United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
| United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
| United States | Texas Cancer Center of Mesquite | Mesquite | Texas |
| United States | Allison Cancer Center | Midland | Texas |
| United States | Minnesota Oncology Hematology, PA | Minneapolis | Minnesota |
| United States | Florida Cancer Institute | New Port Richey | Florida |
| United States | Virginia Oncology Associates | Newport News | Virginia |
| United States | Northwest Medical Specialists, PC | Niles | Illinois |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Ocala Oncology Center | Ocala | Florida |
| United States | West Texas Cancer Center | Odessa | Texas |
| United States | Cancer Care Associates - Baptist Campus | Oklahoma City | Oklahoma |
| United States | Florida Oncology Associates | Orange Park | Florida |
| United States | Cancer Centers of Florida | Orlando | Florida |
| United States | Onc/Hem Associates of Central Illinois | Peoria | Illinois |
| United States | Temple Cancer Center | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Hematology & Oncology Associates | Phoenix | Arizona |
| United States | Oncology-Hematology Associates | Pittsburgh | Pennsylvania |
| United States | Lauderhill Lakes | Plantation | Florida |
| United States | Ranier Oncology Professional Services | Puyallup | Washington |
| United States | Raleigh Hematology Oncology Clinic | Raleigh | North Carolina |
| United States | Raleigh Hematology Oncology Clinic | Raleigh | North Carolina |
| United States | Interlakes Oncology & Hematology, P.C. | Rochester | New York |
| United States | Oncology & Hematology Associates of South West Virginia, Inc. | Salem | Virginia |
| United States | Utah Cancer Specialists | Salt Lake City | Utah |
| United States | an Antonio Tumor and Blood Clinic | San Antonio | Texas |
| United States | Hematology Oncology Associates of South Texas | San Antonio | Texas |
| United States | Sharp Clinical Oncology Research | San Diego | California |
| United States | Scripps Cancer Center | SanDiego | California |
| United States | New Mexico Cancer Center Associates | Santa Fe | New Mexico |
| United States | Redwood Regional Medical Group | Santa Rosa | California |
| United States | Washington Cancer Center, P.C.Puget Sound Cancer Cente | Seattle | Washington |
| United States | Northern Arizona Hematology & Oncology Associates | Sedona | Arizona |
| United States | Hematology Oncology Associates of Illinois | Skokie | Illinois |
| United States | Cancer Care Northwest | Spokane | Washington |
| United States | The Center for Cancer Care & Research | St. Louis | Missouri |
| United States | Minnesota Oncology Hematology, PA | St. Paul | Minnesota |
| United States | MultiCare Health System | Tacoma | Washington |
| United States | Rocky Mountain Cancer Centers | Thornton | Colorado |
| United States | Central Maryland Oncology Group | Towson | Maryland |
| United States | Arizona Clinical Research Center | Tucson | Arizona |
| United States | Cancer Care Associates | Tulsa | Oklahoma |
| United States | Tyler Cancer Center | Tyler | Texas |
| United States | Northwest Cancer Specialists, PC | Vancouver | Washington |
| United States | Waco Cancer Care & Research Center | Waco | Texas |
| United States | Deke Slayton Cancer Center | Webster | Texas |
| United States | Texoma Cancer Center | Wichita Falls | Texas |
| United States | Piedmont Hematology Onccology Associates, P.A. | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc | OSI Pharmaceuticals |
United States,
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
| Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
| Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
| Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
| Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
| Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
| Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
| Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |