Non-Small Cell Lung CancerPhase 3NCT00085826
A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients
A Phase 3 study testing Exisulind in people with Non-Small Cell Lung Cancer, run by Astellas Pharma Inc at 114 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Exisulind
- How many people
- 600 participants
- Where
- 114 sitesUnited States
- Study dates
- Apr 2001to Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Exclusion Criteria:
Trial locations and contacts
114 sites in 1 country.
114 sites in 1 country
United States114 sites
Texas Oncology, PA
Abilene, Texas, 79601-2301
New York Oncology Hematology, PC
Albany, New York, 12208
New York Oncology Hematology
Albany, New York, 12208
Texas Oncology, P.A
Arlington, Texas, 76012
Asheville Hematology & Oncology Associates, PA
Asheville, North Carolina, 28801
South Austin Cancer Center
Austin, Texas, 78745
Mamie McFadden Ward Cancer Center
Beaumont, Texas, 77702-1449
Texas Oncology, P.A.
Bedford, Texas, 76022
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, 59101
Birmingham Hematology Oncology Associates
Birmingham, Alabama, 35205
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35235
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, 33428
Comprehensive Cancer Care Specialists at Boca Raton
Boca Raton, Florida, 33428
Rocky Mountain Cancer Center
Boulder, Colorado, 80304
HemOnCare, PC
Brooklyn, New York, 11235
Raleigh Hematology Oncology Clini
Cary, North Carolina, 27511
Iowa Cancer Care, PLC
Cedar Rapids, Iowa, 52403
Iowa Oncology Associates
Cedar Rapids, Iowa, 52403
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80909
Central Maryland Oncology Center
Columbia, Maryland, 21044
Missouri Cancer Associates
Columbia, Missouri, 65201
US Oncology Research
Dallas, Texas, 75204
Texas Cancer Center at Medical City
Dallas, Texas, 75230-2510
Texas Onclology, PA
Dallas, Texas, 75231
The Texas Cancer Center - Dallas Southwest
Dallas, Texas, 75237
Texas Oncology, PA
Dallas, Texas, 75246
Texoma Cancer Center
Denison, Texas, 75020-2088
RMCC
Denver, Colorado, 80218
Hematology & Oncolgy Assoc of NE PA
Dunmore, Pennsylvania, 18512
Regional Hamatology Oncology Associates
Durham, North Carolina, 27704
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733
Puget Sound Cancer Centers
Edmonds, Washington, 98026
12. Rocky Mountain Cancer Centers-Englewood
Englewood, Colorado, 80110
Rocky Mountain Cancer Centers
Englewood, Colorado, 80110
Willamette Valley Cancer Center
Eugene, Oregon, 97401
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Fairfax Northern Virginia Hematology-Oncology, PC
Fairfax, Virginia, 22031
Northern Arizona Hematology and Oncology Associates
Flagstaff, Arizona, 86001
Rocky Mountain Cancer Centers
Fort Collins, Colorado, 80524
Texas Cancer Center
Fort Worth, Texas, 76104
Texas Oncology, PA
Fort Worth, Texas, 76104
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, 92708
Impath Predictive Oncology
Franklin, Massachusetts, 02038
San Antonio Tumor and Blood Clinic
Fredicksburg, Texas, 78624
Texas Oncology, PA
Garland, Texas, 75042-5788
Cancer Research of Long Island
Great Neck, New York, 11023
California Cancer Care, Inc.
Greenbrae, California, 94904
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
Northeastern Carolina Hematology & Oncology, PA
Hickory, North Carolina, 28602
Texas Oncology, PA
Houston, Texas, 77024
Texas Oncology, PA
Houston, Texas, 77029
Texas Oncology, PA
Houston, Texas, 77030
Texas Oncology, PA
Houston, Texas, 77074-1811
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227
Texas Oncology, PA
Irving, Texas, 75061
North Florida Hematology & Oncology Association
Jacksonville, Florida, 32204
Florida Oncology Associates
Jacksonville, Florida, 32207
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111
Dayton Oncology/Hematology, PA
Kettering, Ohio, 45409
Medical Oncology Associates of Wymoning Valley, PC
Kingston, Pennsylvania, 18704
South Florida Oncology & Hematology Consultants
Lauderhill, Florida, 33319
Lake Vista Cancer Center
Lewisville, Texas, 75067
Arkansas Oncology Associates, PA
Little Rock, Arkansas, 72207
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150
Allison Cancer Center
Midland, Texas, 79701-5946
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404
Florida Cancer Institute
New Port Richey, Florida, 34655
Virginia Oncology Associates
Newport News, Virginia, 23606
Northwest Medical Specialists, PC
Niles, Illinois, 60714
Virginia Oncology Associates
Norfolk, Virginia, 23502
Ocala Oncology Center
Ocala, Florida, 34474
West Texas Cancer Center
Odessa, Texas, 79761
Cancer Care Associates - Baptist Campus
Oklahoma City, Oklahoma, 73112
Florida Oncology Associates
Orange Park, Florida, 32073
Cancer Centers of Florida
Orlando, Florida, 32806
Onc/Hem Associates of Central Illinois
Peoria, Illinois, 61602
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Temple Cancer Center
Philadelphia, Pennsylvania, 19140
Hematology & Oncology Associates
Phoenix, Arizona, 85012
Oncology-Hematology Associates
Pittsburgh, Pennsylvania, 15215
Lauderhill Lakes
Plantation, Florida, 33324
Ranier Oncology Professional Services
Puyallup, Washington, 98372
Raleigh Hematology Oncology Clinic
Raleigh, North Carolina, 27607
Raleigh Hematology Oncology Clinic
Raleigh, North Carolina, 27609
Interlakes Oncology & Hematology, P.C.
Rochester, New York, 14623
Minnesota Oncology Hematology, PA
Saint Paul, Minnesota, 55102
Oncology & Hematology Associates of South West Virginia, Inc.
Salem, Virginia, 24153
Utah Cancer Specialists
Salt Lake City, Utah, 84106
an Antonio Tumor and Blood Clinic
San Antonio, Texas, 78217
Hematology Oncology Associates of South Texas
San Antonio, Texas, 78229
Study site
San Antonio, Texas
Scripps Cancer Center
San Diego, California, 92121
Sharp Clinical Oncology Research
San Diego, California, 92123
New Mexico Cancer Center Associates
Santa Fe, New Mexico, 87501
Redwood Regional Medical Group
Santa Rosa, California, 95403
Washington Cancer Center, P.C.Puget Sound Cancer Cente
Seattle, Washington, 98133
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336
Hematology Oncology Associates of Illinois
Skokie, Illinois, 60077
Cancer Care Northwest
Spokane, Washington, 99218
The Center for Cancer Care & Research
St Louis, Missouri, 63141
MultiCare Health System
Tacoma, Washington, 98405
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260
Central Maryland Oncology Group
Towson, Maryland, 21204
Arizona Clinical Research Center
Tucson, Arizona, 85715
Cancer Care Associates
Tulsa, Oklahoma, 74136-1902
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684
Waco Cancer Care & Research Center
Waco, Texas, 76712
Deke Slayton Cancer Center
Webster, Texas, 77589
Texoma Cancer Center
Wichita Falls, Texas, 76310
Piedmont Hematology Onccology Associates, P.A.
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Exisulind
- Keywords
- Lung Cancer, NSCLC, Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExisulindDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2004 (estimated)
- Study startApr 2001
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085826
- Sponsor's protocol ID
- 028
- Status last verified
- Oct 2011
- First submitted
- 15 Jun 2004
- Last updated
- 20 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00085826
- Acronym / sponsor ID
- 028
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Lung Cancer, NSCLC, Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Study start
- Apr 2001
- Study completion
- Dec 2004 (actual)
- First posted
- 17 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exisulind | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
114 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exisulind in people with Non-Small Cell Lung Cancer, run by Astellas Pharma Inc at 114 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 114 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2011.