Lung NeoplasmsPhase 2NCT00826852
Weekly Docetaxel and Four Weekly Carboplatin in Non-small Cell Lung Cancer Carbo-Tax
A Phase 2 study testing docetaxel and carboplatin in people with Lung Neoplasms, run by Sanofi at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is: to assess the efficacy of the combination in terms of Objective (clinical and radiological) Response Rate to assess the time to progression of the disease; assess the safety profile of the combination, and assess the survival time. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- docetaxel and carboplatin
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2003to Jul 2009
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically/cytologically confirmed inoperable locally advanced or metastatic non-small cell lung cancer
- ECOG Performance Status is 0-2
- At least one measurable lesion in two dimensions by means of CT scan
- No brain metastases
- No prior chemotherapy for this malignancy,
- Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance measured in 24 hours urine ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 2.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
Who cannot join
- Concomitant use of another anti-cancer therapy
- Chemotherapy, radiotherapy or curative surgery
- Evidence of intracerebral metastasis
- Unstable medical condition that makes the patient to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural or peritoneal effusion; or presence of serious uncontrolled infection, diarrhea, ileus, interstitial pneumonia, pulmonary fibrosis.
- Presence of other tumours different from basal cell carcinoma of the skin, with disease free survival less then 3 years.
- Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
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- Social or psychological condition that render the patient inadequate for the follow-up of the study
- Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Weekly Docetaxel and Four Weekly Carboplatin Combination in the First-line Treatment of Advanced Non-small Cell Lung Cancer
The purpose of this study is:
- to assess the efficacy of the combination in terms of Objective (clinical and radiological) Response Rate
- to assess the time to progression of the disease; assess the safety profile of the combination, and assess the survival time.
- Conditions
- Lung Neoplasms
- Being tested
- docetaxel and carboplatin
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel and carboplatinDrug
weekly docetaxel 30mg/m2 and four weekly carboplatin AUC (Area under curve) 5
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy by response rate
Measured: After the 3rd cycle, 6th cycle and at every follow up visit
Secondary outcomes (3)
Adverse events
Measured: At each visit
Efficacy by time to progression
Measured: Until the progression of all patients
Overall survival
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startOct 2003
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edibe Taylan, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826852
- Sponsor's protocol ID
- XRP6976B_6020
- Status last verified
- Jul 2010
- First submitted
- 13 Oct 2008
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Weekly Docetaxel and Four Weekly Carboplatin Combination in the First-line Treatment of Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00826852
- Acronym / sponsor ID
- XRP6976B_6020
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Jan 2009 (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 assess the efficacy of the combination in terms of Objective (clinical and radiological) Response Rate
- to assess the time to progression of the disease; assess the safety profile of the combination, and assess the survival time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically/cytologically confirmed inoperable locally advanced or metastatic non-small cell lung cancer
- ECOG Performance Status is 0-2
- At least one measurable lesion in two dimensions by means of CT scan
- No brain metastases
- No prior chemotherapy for this malignancy,
Key exclusion criteria (9 listed)
- Concomitant use of another anti-cancer therapy
- Chemotherapy, radiotherapy or curative surgery
- Evidence of intracerebral metastasis
- Unstable medical condition that makes the patient to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural or peritoneal effusion; or presence of serious uncontrolled infection, diarrhea, ileus, interstitial pneumonia, pulmonary fibrosis.
- Presence of other tumours different from basal cell carcinoma of the skin, with disease free survival less then 3 years.
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 |
|---|---|---|
| docetaxel and carboplatinweekly docetaxel 30mg/m2 and four weekly carboplatin AUC (Area under curve) 5 | Drug | – |
Primary outcome
Efficacy by response rate
Time frame: After the 3rd cycle, 6th cycle and at every follow up visit
3 secondary outcomes
Adverse events
Time frame: At each visit
Efficacy by time to progression
Time frame: Until the progression of all patients
Overall survival
Time frame: At the end of the study
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 27 Jul 2010.
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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.
Edibe Taylan, MD study director
Sanofi
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 docetaxel and carboplatin in people with Lung Neoplasms, run by Sanofi at 1 site in Turkey (Türkiye).
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 6 inclusion and 9 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 27 Jul 2010. 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 Turkey (Türkiye). 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?
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?
Efficacy by response rate (time frame: After the 3rd cycle, 6th cycle and at every follow up visit). 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 27 Jul 2010.