Carcinoma, Non-Small-Cell LungPhase 3NCT00035152
Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer
A Phase 3 study testing Paclitaxel and carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 56 sites in United States.
Trial summary
Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small cell lung carcinoma. This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where it is given weekly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Paclitaxel and carboplatin
- How many people
- 444 participants
- Where
- 56 sitesUnited States
- Study dates
- Jun 2000to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of non-small cell bronchogenic carcinoma (epidermoid, squamous, adeno, large cell anaplastic carcinoma, but no small cell or carcinoid) must be histologically or cytologically confirmed.
- No prior antineoplastic chemotherapy, hormonal therapy or therapy with biological response modifiers
- No previous irradiation to the only area of measurable disease.
Who cannot join
- Past or current history of neoplasm other than the entry diagnosis. Exceptions are curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other cancers treated by surgery or radiation with a disease free survival longer than 5 years.
- Patients who have undergone surgery less than 3 weeks prior to enrollment.
- History of serious cardiac disease not adequately controlled.
- Patients with serious active infections or other serious underlying medical condition.
- Uncontrolled diabetes mellitis.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Don & Sybil Harrington Cancer Center
Amarillo, Texas, 79106
Advanced Oncology Associates
Armonk, New York, 10504
Wellstar Cobb Hospital
Austell, Georgia, 30060
Brackenridge Hospital
Austin, Texas, 78701
Southwest Regional Cancer Center
Austin, Texas, 78705
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brooklyn VA
Brooklyn, New York, 11209
Maimonides Medical Center
Brooklyn, New York, 11209
Raleigh Hematology Associates, Wake Practice
Cary, North Carolina, 27609
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
Clifton Springs Hospital and Clinic
Clifton Springs, New York, 14432
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
Columbus CCOP
Columbus, Ohio, 43206
Danbury Hospital/Praxair Cancer Center
Danbury, Connecticut, 06810
Goshen Medical Associates
Goshen, New York, 10924
Quadrangle Medical Specialists, Southern Oncology Research
Greenville, North Carolina, 27834
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Community Cancer Care, Inc.
Indianapolis, Indiana, 46202
Hematology and Oncology Associates of Southern Michigan,P.C
Jackson, Michigan, 49201
Joliet Oncology/Hematology Associates,Ltd.
Joliet, Illinois, 60435
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
New York Oncology-Hematology,P.C./Capital District Hematology, Oncology Associates
Latham, New York, 12110
Central Pennsylvania Hematology & Medical Oncology Associates, P.C.
Lemoyne, Pennsylvania, 17043
Little Rock Hematology/Oncology Associates
Little Rock, Arkansas, 72205
Jewish Medical Plaza
Louisville, Kentucky, 40202
University of Louisville
Louisville, Kentucky, 40202
Southwest Cancer Center
Lubbock, Texas, 79415
Mercy Cancer Center
Mason City, Iowa, 50401
Boston Cancer Group, PLC
Memphis, Tennessee, 38104
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Fairview-University Medical Center, University of Minnesota
Minneapolis, Minnesota, 55455
Hematology/Oncology of Rockland
New York, New York
Mid Illinois Hematology and Oncology Associates, Ltd.
Normal, Illinois, 61761
Creighton University Cancer Center
Omaha, Nebraska, 68131
Medical Oncology Care Associates
Orange, California, 92868
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
Hematology-Oncology of Central New Jersey
Red Bank, New Jersey, 07701
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
Upstate New York Cancer R & E
Rochester, New York, 14623
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55416
Naval Medical Center
San Diego, California, 92134
Guthrie Clinic Ltd
Sayre, Pennsylvania, 18840
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130
Siouxland Hematology/Oncology Associates
Sioux City, Iowa, 51101
Highlands Oncology Group
Springdale, Arkansas, 72764
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Madigan Army Medical Center
Tacoma, Washington, 98431
Associated Physicians & Surgeons Clinic, LLC
Terre Haute, Indiana, 47804
Community Medical Center
Toms River, New Jersey, 08755
Walter Reed Army Hospital
Washington D.C., District of Columbia, 20307
Washington VA Medical Center
Washington D.C., District of Columbia, 20422
Maine General Medical Center
Waterville, Maine, 04901
Good Samaritan Medical Center
West Palm Beach, Florida, 33401
About this study
Official title: A Multicenter, Randomized Trial for Stage IIIB or IV NSCLC Comparing Weekly Taxol(Paclitaxel) and Carboplatin(Paraplatin) Regimen Versus Standard Taxol and Carboplatin Administered Every Three Weeks, Followed by Weekly Taxol.
Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small cell lung carcinoma.
This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where it is given weekly.
The purpose of the study is to determine the most effective and safe schedule for giving these drugs in non small cell lung carcinoma.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Paclitaxel and carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel and carboplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startJun 2000
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 444 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035152
- Sponsor's protocol ID
- BMS TAX/MEN.12
- Status last verified
- Sep 2016
- First submitted
- 2 May 2002
- Last updated
- 19 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Trial for Stage IIIB or IV NSCLC Comparing Weekly Taxol(Paclitaxel) and Carboplatin(Paraplatin) Regimen Versus Standard Taxol and Carboplatin Administered Every Three Weeks, Followed by Weekly Taxol.
- ClinicalTrials.gov ID
- NCT00035152
- Acronym / sponsor ID
- BMS TAX/MEN.12
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Study completion
- Dec 2004
- First posted
- 3 May 2002 (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.
Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small cell lung carcinoma.
This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where it is given weekly.
The purpose of the study is to determine the most effective and safe schedule for giving these drugs in non small cell lung carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmation of non-small cell bronchogenic carcinoma (epidermoid, squamous, adeno, large cell anaplastic carcinoma, but no small cell or carcinoid) must be histologically or cytologically confirmed.
- No prior antineoplastic chemotherapy, hormonal therapy or therapy with biological response modifiers
- No previous irradiation to the only area of measurable disease.
Key exclusion criteria (5 listed)
- Past or current history of neoplasm other than the entry diagnosis. Exceptions are curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other cancers treated by surgery or radiation with a disease free survival longer than 5 years.
- Patients who have undergone surgery less than 3 weeks prior to enrollment.
- History of serious cardiac disease not adequately controlled.
- Patients with serious active infections or other serious underlying medical condition.
- Uncontrolled diabetes mellitis.
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 |
|---|---|---|
| Paclitaxel and carboplatin | 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 19 Sep 2016.
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
56 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 Paclitaxel and carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 56 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 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 19 Sep 2016.