Carcinoma, Non-Small-Cell LungPhase 2NCT00168883
Study for Patients With Non Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Carboplatin, Paclitaxel and Vinorelbine in people with Carcinoma, Non-Small-Cell Lung, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin. 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?
- Carboplatin, Paclitaxel and Vinorelbine
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2002to Dec 2006
- Phase
- Phase 2
- 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
- Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV
Who cannot join
- New York Heart Association (NYHA) III or IV
- Brain metastases
- Neurotoxicity Grade 2 or greater
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hematology & Oncology Charité CBF Berlin
Berlin, State of Berlin, 12203
Ulrich Keilholz, MD, +49-30-8445-3596, ulrich.keilholz@charite.de
Alexander Schmittel, MD, +49-30-8445-3090, alexander.schmittel@charite.de
About this study
Official title: Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV
This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.
Read the detailed description
Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Carboplatin, Paclitaxel, Vinorelbine
- Keywords
- NSCLC, curative non-treatable NSCLC UICC stage IIIB and IV
- 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.
CarboplatinDrug
PaclitaxelDrug
VinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of response rate (stable disease [SD] or better)
Determination of safety of the combination and life quality
Secondary outcomes (3)
Determination of remission rate
Determination of time to progression
Determination of 1-year survival rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2002
- Study completionDec 2006
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 Charite University, Berlin, GermanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pierre Fabre Pharma GmbH
- Investigators
- Ulrich Keilholz, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168883
- Sponsor's protocol ID
- Haema CBF NSCLC UK/AS 03
- Status last verified
- Sep 2006
- First submitted
- 9 Sep 2005
- Last updated
- 1 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV
- ClinicalTrials.gov ID
- NCT00168883
- Acronym / sponsor ID
- Haema CBF NSCLC UK/AS 03
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC, curative non-treatable NSCLC UICC stage IIIB and IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pierre Fabre Pharma GmbH
- Study start
- Oct 2002
- Study completion
- Dec 2006
- First posted
- 15 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.
This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.
Detailed description
Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (1 listed)
- Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV
Key exclusion criteria (3 listed)
- New York Heart Association (NYHA) III or IV
- Brain metastases
- Neurotoxicity Grade 2 or greater
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 |
|---|---|---|
| Carboplatin | Drug | – |
| Paclitaxel | Drug | – |
| Vinorelbine | Drug | – |
Primary outcome
Determination of response rate (stable disease [SD] or better)
Determination of safety of the combination and life quality
3 secondary outcomes
Determination of remission rate
Determination of time to progression
Determination of 1-year survival rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2006.
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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.
Ulrich Keilholz, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Paclitaxel and Vinorelbine in people with Carcinoma, Non-Small-Cell Lung, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Keilholz, MD (+49-30-8445-3596, ulrich.keilholz@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of response rate (stable disease [SD] or better). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 1 Nov 2006.