Non-small Cell Lung CancerPhase 2NCT00425191
Taxotere Combinations as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.
A Phase 2 study testing Docetaxel and Gemcitabine and Gemcitabine cisplatin followed by docetaxel in people with Non-small Cell Lung Cancer, run by Sanofi at 1 site in Italy.
Trial summary
To assess the antitumour activity (response rate) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as first line chemotherapy · To evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Docetaxel and Gemcitabine and Gemcitabine cisplatin followed by docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2002to Apr 2005
- 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 istologic 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;
- Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented whenever possible;
- Weight loss < = 5% within the last 3 months;
- Laboratory requirements at entry :
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- Blood cell counts: Absolute neutrophils > 2.0 x 109/LPlatelets > 100 x 109/LHemoglobin > 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 UNLASAT and ALAT < 2.5 x UNLAlkaline phosphatase < 5 x UNL (unless accompanied by extensive bone metastases);
Who cannot join
- Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments;
- Prior radiotherapy for NSCLC;
- Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
- Patients with not measurable disease only;
- Patients with symptomatic brain metastases or with leptomeningeal disease. However; patients with symptomatic brain metastases who become asymptomatic under corticosteriods treatment can enter the study;
- 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);
- Concurrent treatment with other experimental drugs;
- Current peripheral neuropathy NCI grade > = 2;
- Significant neurological or psychiatric disorders;
- Hepatic functions abnormalities;
- Participation in clinical trials with other experimental agents within 30 days of study entry;
- Other serious concomitant illness of medical conditions;
- 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, undoes risk or interferes with the study.
- Treatment with biphosphonates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.
To assess the antitumour activity (response rate) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each treatment arms.· To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.· To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Docetaxel and Gemcitabine, Gemcitabine cisplatin followed by docetaxel
- 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 GemcitabineDrug
Docetaxel: 40 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 8 immediately followed by Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8
Docetaxel and GemcitabineDrug
Docetaxel: 50 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 15 immediately followed by Gemcitabine: 1600 mg/m2, administered IV over 30 minutes on day 1 and 15.
Gemcitabine cisplatin followed by docetaxelDrug
Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 followed by Cisplatin 75 mg/m2, administered IV over 30-60 minutes on day 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Docetaxel and Gemcitabine |
| 2 | Experimental | Not described Receives: Drug: Docetaxel and Gemcitabine |
| 3 | Experimental | Not described Receives: Drug: Gemcitabine cisplatin followed by docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: Performed after 3 cycles and at the end of treatment (6 cycles).
Secondary outcomes (1)
Time to progression.
Measured: Time from treatment to the documented profession of disease.
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 startJul 2002
- Primary completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- 165 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
- NCT00425191
- Sponsor's protocol ID
- XRP6976B_2501
- 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
- A Multicenter, Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00425191
- Acronym / sponsor ID
- XRP6976B_2501
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Apr 2005 (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.
To assess the antitumour activity (response rate) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each treatment arms.· To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.· To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel and Gemcitabine |
| 2 | Experimental | Drug: Docetaxel and Gemcitabine |
| 3 | Experimental | Drug: Gemcitabine cisplatin followed by docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed diagnosis of NSCLC istologic 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;
- Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented whenever possible;
- Weight loss < = 5% within the last 3 months;
Key exclusion criteria (19 listed)
- Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments;
- Prior radiotherapy for NSCLC;
- Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
- Patients with not measurable disease only;
- Patients with symptomatic brain metastases or with leptomeningeal disease. However; patients with symptomatic brain metastases who become asymptomatic under corticosteriods treatment can enter the study;
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 GemcitabineDocetaxel: 40 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 8 immediately followed by Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 | Drug | 1 |
| Docetaxel and GemcitabineDocetaxel: 50 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 15 immediately followed by Gemcitabine: 1600 mg/m2, administered IV over 30 minutes on day 1 and 15. | Drug | 2 |
| Gemcitabine cisplatin followed by docetaxelGemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 followed by Cisplatin 75 mg/m2, administered IV over 30-60 minutes on day 2 | Drug | 3 |
Primary outcome
Response Rate
Time frame: Performed after 3 cycles and at the end of treatment (6 cycles).
1 secondary outcome
Time to progression.
Time frame: Time from treatment to the documented profession of disease.
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 Gemcitabine and Gemcitabine cisplatin followed by docetaxel in people with Non-small Cell Lung Cancer, 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 9 inclusion and 19 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?
Response Rate (time frame: Performed after 3 cycles and at the end of treatment (6 cycles).). 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.