Lung CancerPhase 3NCT00193362
Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer
A Phase 3 study testing Paclitaxel, Carboplatin and Gemcitabine in people with Lung Cancer, run by SCRI Development Innovations, LLC.
Trial summary
The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Paclitaxel, Carboplatin and Gemcitabine
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Sep 2007
- 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
- To be included in this study, you must meet the following criteria:
- Non-small cell bronchogenic carcinoma
- Newly diagnosed unresectable stage IIIB or stage IV disease
- Patients with stage IIIB disease should be ineligible for combined therapy
- Patients must have measurable lesion definable by X-ray or CT scan.
- No prior antineoplastic chemotherapy for lung cancer prior to study entry
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- Age > 18 years
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
- Written informed consent must be obtained prior to study entry
- Patients must be available for treatment and followup.
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Female patient pregnant or lactating
- History of heart disease
- Serious active infection at the time of treatment
- Other serious underlying medical condition
- Brain metastasis
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- Patients without measurable disease
- Uncontrolled diabetes mellitus defined as random blood sugar > 250mg/dL
- Dementia or significantly altered mental status
- Significant peripheral neuropathy by history or physical examination.
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
About this study
Official title: Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer
The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer
Read the detailed description
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- Paclitaxel + Carboplatin + Gemcitabine
- Gemcitabine + Vinorelbine
For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
- Conditions
- Lung Cancer
- Being tested
- Paclitaxel, Carboplatin, Gemcitabine, Vinorelbine
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
CarboplatinDrug
GemcitabineDrug
VinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival.
Secondary outcomes (4)
Overall toxicity
Overall response rate
Time-to-progression
Assess the quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, GlaxoSmithKline
- Investigators
- Anthony Greco, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193362
- Sponsor's protocol ID
- SCRI LUN 54
- Other IDs
- B9E-MC-X338, VNR-R47
- Status last verified
- Jul 2010
- First submitted
- 12 Sep 2005
- Last updated
- 28 Jul 2010
- Results posted
- No
Publications
Greco FA, Spigel DR, Kuzur ME, Shipley D, Gray JR, Thompson DS, Burris HA, Yardley DA, Pati A, Webb CD, Gandhi JG, Hainsworth JD. Paclitaxel/Carboplatin/gemcitabine versus gemcitabine/vinorelbine in advanced non-small-cell lung cancer: a phase II/III study of the Minnie Pearl Cancer Research Network. Clin Lung Cancer. 2007 Sep;8(8):483-7. doi: 10.3816/CLC.2007.n.032.
PubMed 17922972
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00193362
- Acronym / sponsor ID
- SCRI LUN 54
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, GlaxoSmithKline
- Study start
- Jun 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 19 Sep 2005 (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.
The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer
Detailed description
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- Paclitaxel + Carboplatin + Gemcitabine
- Gemcitabine + Vinorelbine
For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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 (11 listed)
- Non-small cell bronchogenic carcinoma
- Newly diagnosed unresectable stage IIIB or stage IV disease
- Patients with stage IIIB disease should be ineligible for combined therapy
- Patients must have measurable lesion definable by X-ray or CT scan.
- No prior antineoplastic chemotherapy for lung cancer prior to study entry
Key exclusion criteria (11 listed)
- Female patient pregnant or lactating
- History of heart disease
- Serious active infection at the time of treatment
- Other serious underlying medical condition
- Brain metastasis
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 | Drug | – |
| Carboplatin | Drug | – |
| Gemcitabine | Drug | – |
| Vinorelbine | Drug | – |
Primary outcome
Overall survival.
4 secondary outcomes
Overall toxicity
Overall response rate
Time-to-progression
Assess the quality of life
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 28 Jul 2010.
- Results publication: PubMed 17922972Greco FA, Spigel DR, Kuzur ME, Shipley D, Gray JR, Thompson DS, Burris HA, Yardley DA, Pati A, Webb CD, Gandhi JG, Hainsworth JD. Paclitaxel/Carboplatin/gemcitabine versus gemcitabine/vinorelbine in advanced non-small-cell lung cancer: a phase II/III study of the Minnie Pearl Cancer Research Network. Clin Lung Cancer. 2007 Sep;8(8):483-7. doi: 10.3816/CLC.2007.n.032.
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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.
Anthony Greco, MD principal investigator
SCRI Development Innovations, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel, Carboplatin and Gemcitabine in people with Lung Cancer, run by SCRI Development Innovations, LLC.
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 11 inclusion and 11 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 28 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Overall survival.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00193362, which also lists 1 linked publication.
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 28 Jul 2010.