Carcinoma, Non-Small-Cell LungPhase 2NCT00424853
ADVANCED Phase II Trial of Weekly vs 3 Weekly Docetaxel and Cisplatin Followed by Gemcitabine in Non-small-cell Lung Cancer (NSCLC)
A Phase 2 study testing Docetaxel and cisplatin followed by gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by Sanofi at 1 site in Italy.
Trial summary
This is a multicenter, open-label, randomized phase II trial whose aim is to assess the antitumor activity of two sequential schedules of docetaxel and cisplatin followed by gemcitabine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Docetaxel and cisplatin followed by gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- May 2005to Aug 2008
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of NSCLC; Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC;
- Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System;
- Patients must have at least one measurable lesion according to RECIST criteria.
- Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented;
- WHO Performance Status 0 or 1 ;
- Weight loss < 5% within the last 3 months;
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- Laboratory requirements at entry
- Blood cell counts: Absolute neutrophils > 2.0 . 10^9/L; Platelets > 100 . 10^9/L; Hemoglobin > 10 g/dl
- Renal function: Serum creatinine < 1 upper normal limits (UNL). In case of limit value of serum creatinine, the creatinine clearance should be > 60 mL/min
- Hepatic functions: Serum bilirubin < 1 x UNL; ASAT and ALAT < 2.5 x UNL; Alkaline phosphatase < 5 x UNL (unless accompanied by extensive bone metastases)
Who cannot join
- Prior systemic chemotherapy or immunotherapy ; prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment;
- Prior radiotherapy for NSCLC to measurable lesions. Prior radiotherapy (to < 25% of the bone marrow) is allowed in non target lesions. At least 4 weeks must be elapsed since the completion of the radiotherapy and the patient must have all side effects recovered.
- Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
- Patients with evaluable, not measurable disease only (non target lesions);
- Patients with symptomatic brain metastases or with leptomeningeal disease;
- History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years;
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- History of hypersensitivity reaction to polysorbate 80;
- Pregnant or lactating women (women of childbearing potential must use adequate contraception);
- Current peripheral neuropathy NCI grade > 2;
- Significant neurological or psychiatric disorders ;
- Participation in clinical trials with other experimental agents within 30 days of study entry;
- Other serious concomitant illness of medical conditions:
- Uncontrolled cardiovascular disease;
- History of significant neurologic or psychiatric disorders including demential or seizures;
- Active infection requiring iv antibiotics;
- Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy;
- Any other condition which in the judgement of the investigator would place the subject at undue risk or interfere with the study.
- 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: Randomized Phase II Trial of Two Sequential Schedules of Docetaxel and Cisplatin Followed by Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer.
This is a multicenter, open-label, randomized phase II trial whose aim is to assess the antitumor activity of two sequential schedules of docetaxel and cisplatin followed by gemcitabine.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Docetaxel and cisplatin followed by gemcitabine
- 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.
Docetaxel and cisplatin followed by gemcitabineDrug
docetaxel 75 mg/m2 day 1 + cisplatin 75 mg/m2 day1 repeated every 21 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles
docetaxel and cisplatin followed by gemcitabineDrug
docetaxel 25 mg/m2 day 1,8,15 + cisplatin 25 mg/m2 days1,8,15 repeated every 28 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Docetaxel and cisplatin followed by gemcitabine |
| B | Experimental | Not described Receives: Drug: docetaxel and cisplatin followed by gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate assessed by RECIST criteria.
Measured: before, during and at the end of treatment
Secondary outcomes (3)
Time to progression
Measured: from the date of randomization to the date of first documented tumor progression or relapse
time to treatment failure
Measured: from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administraztion of other antitumor treatment, or death for any cause
overall survival
Measured: time interval from the date of randomisation to the date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startMay 2005
- Primary completionAug 2008
- Study completionAug 2008
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Georges Paizis, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424853
- Sponsor's protocol ID
- XRP6976B_2506
- Other IDs
- EudraCT # : 2004-001044-72
- Status last verified
- Dec 2009
- First submitted
- 19 Jan 2007
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Two Sequential Schedules of Docetaxel and Cisplatin Followed by Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00424853
- Acronym / sponsor ID
- XRP6976B_2506
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Jan 2007 (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 multicenter, open-label, randomized phase II trial whose aim is to assess the antitumor activity of two sequential schedules of docetaxel and cisplatin followed by gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Docetaxel and cisplatin followed by gemcitabine |
| B | Experimental | Drug: docetaxel and cisplatin followed by gemcitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed diagnosis of NSCLC; Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC;
- Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System;
- Patients must have at least one measurable lesion according to RECIST criteria.
- Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented;
- WHO Performance Status 0 or 1 ;
Key exclusion criteria (18 listed)
- Prior systemic chemotherapy or immunotherapy ; prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment;
- Prior radiotherapy for NSCLC to measurable lesions. Prior radiotherapy (to < 25% of the bone marrow) is allowed in non target lesions. At least 4 weeks must be elapsed since the completion of the radiotherapy and the patient must have all side effects recovered.
- Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
- Patients with evaluable, not measurable disease only (non target lesions);
- Patients with symptomatic brain metastases or with leptomeningeal disease;
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 cisplatin followed by gemcitabinedocetaxel 75 mg/m2 day 1 + cisplatin 75 mg/m2 day1 repeated every 21 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles | Drug | A |
| docetaxel and cisplatin followed by gemcitabinedocetaxel 25 mg/m2 day 1,8,15 + cisplatin 25 mg/m2 days1,8,15 repeated every 28 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles. | Drug | B |
Primary outcome
overall response rate assessed by RECIST criteria.
Time frame: before, during and at the end of treatment
3 secondary outcomes
Time to progression
Time frame: from the date of randomization to the date of first documented tumor progression or relapse
time to treatment failure
Time frame: from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administraztion of other antitumor treatment, or death for any cause
overall survival
Time frame: time interval from the date of randomisation to the date of death
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 7 Dec 2009.
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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.
Georges Paizis, 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 cisplatin followed by gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by Sanofi at 1 site in Italy.
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 10 inclusion and 18 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 7 Dec 2009. 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 Italy. 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?
overall response rate assessed by RECIST criteria. (time frame: before, during and at the end of treatment). 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 7 Dec 2009.