Lung NeoplasmsPhase 3NCT00174629
GILT Docetaxel - Non-Small Cell Lung Cancer
A Phase 3 study testing Docetaxel/DDP and docetaxel/gemcitabine in people with Lung Neoplasms, run by Sanofi at 3 sites in 3 countries.
Trial summary
Primary Objective: To compare response rate between genotypic groups and control group. Secondary Objective: To determine the safety, time to treatment failure and survival in control and genotypic arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Docetaxel/DDP and docetaxel/gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2001to Jan 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
- Patients must be/have:
- histologically confirmed non-small cell lung cancer (squamous cell carcinoma, large cells or adenocarcinoma; it is recommended to provide the full paraffin-embedded block or at least 5 5 sections obtained from the primary tumor, recurrence or metastasis, not stained, fixed in formalin/embedded in paraffin, mounted on slides (10 micron sections), as well as two serum samples in two 10-ml tubes and two blood samples (see appendix X);
- unresectable metastatic (stage IV or IIIB malignant pleural effusion) NSCLC;
- WHO performance status < 2;
- Adequate bone marrow, hepatic and renal functions, assessed during the previous 14 days, that should be shown by the following characteristics:
- hemoglobin > or = 10g/dl and no blood cell transfusion within the previous 2 weeks;
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- absolute neutrophil count > 2.0 10^9 cells/l;
- platelet count > or = 100.10^9 cells/l;
- no evidence of myelodysplastic syndrome or abnormal bone marrow reserve;
- creatinine < or = 1.5 x UNL or creatinine clearance > or = 60 ml/min (real or calculated);
- total bilirubin < or = UNL;
- ASAT (SGOT) and/or ALAT (SGPT) < or = 1.5 x UNL;
- alkaline phosphatases < or = 5 x UNL;
- serum calcium < or = 1.1 x UNL;
- at least one measurable lesion;
- previous surgery intervention (more than 30 days before inclusion in the study) is allowed but metastatic disease must be demonstrated;
- previous radiotherapy is allowed if:
- less or equal to 10% of bone marrow has been irradiated
- end of radiotherapy 21 days or more prior to inclusion in the study;
- patient has fully recovered from all toxic effects;
- at least one of the measurable target lesions for evaluation of tumor response has not been irradiated;
- the patient must be accessible for treatment and follow-up. The patient entered into this trial must be treated and followed up at the participating center;
- life expectancy > or = 12 weeks;
- The initial diagnostic procedures should be performed during the 4 weeks prior to the randomization.
Who cannot join
- pregnant or lactating women (women of childbearing potential must use adequate contraception);
- prior systemic chemotherapy or immunotherapy for NSCLC, even as neoadjuvant or adjuvant therapy;
- prior malignancies, except cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with non-evidence of disease for at least 5 years;
- history or clinical symptomatic brain or leptomeningeal metastases;
- current peripheral neuropathy and neurohearing > or = NCIC-CTG grade 2 except if due to trauma;
- other serious illness or medical condition, including:
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- congestive heart disease; prior myocardial infarction within 6 months;
- history of significant neurologic or psychiatric disorders that would inhibit their understanding and giving of informed consent;
- infection requiring I.V. antibiotics and tuberculosis under treatment ongoing at study entry;
- untreated superior vena cava syndrome;
- active peptic ulcer; unstable diabetes mellitus or other contraindication to high dose corticotherapy such as herpes, herpes zoster, cirrhosis;
- hypercalcemia requiring therapy;
- preexisting ascitis and/or clinical significant pericardial effusion;
- patients whose lesion(s) are assessable only by radionuclide scan;
- history of allergy to drugs containing the excipient TWEEN 80®;
- concurrent treatment with other investigational drugs;
- participation in a clinical trial of one or more investigational agents (i.e. antibiotic) or devices within 30 days of study entry.
- 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
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Open-Label, Cooperative, Randomized, Multicenter Phase III Study on the Use of Cisplatin Resistant Genotype (ERCC1 Over-Expression) in Tumor RNA to Customize Chemotherapy in Stage IV-IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer Patients
Primary Objective:
- To compare response rate between genotypic groups and control group.
Secondary Objective:
- To determine the safety, time to treatment failure and survival in control and genotypic arms.
- Conditions
- Lung Neoplasms
- Being tested
- Docetaxel/DDP, docetaxel/gemcitabine
- 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/DDPDrug
docetaxel/gemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: docetaxel/gemcitabine |
| 2 | Active comparator | Not described Receives: Drug: Docetaxel/DDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.
Secondary outcomes (3)
Time to treatment failure and survival
Measured: calculated from the registration date until progression or death, respectively
Clinical and laboratory toxicities graded according to NCIC-CTG Expanded Common Toxicity Criteria.
Measured: before each cycle
Adverse events not reported in NCIC-CTG Expanded Common Toxicity Criteria will be graded as mild, moderate, severe, and life threatening.
Measured: Throughout the study
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 startJun 2001
- Primary completionJan 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Philippe Aussel, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174629
- Sponsor's protocol ID
- TAX_ES1_302
- Status last verified
- Dec 2009
- First submitted
- 9 Sep 2005
- 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
- Open-Label, Cooperative, Randomized, Multicenter Phase III Study on the Use of Cisplatin Resistant Genotype (ERCC1 Over-Expression) in Tumor RNA to Customize Chemotherapy in Stage IV-IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00174629
- Acronym / sponsor ID
- TAX_ES1_302
- Conditions
- Lung Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Jan 2007 (actual)
- 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.
Primary Objective:
- To compare response rate between genotypic groups and control group.
Secondary Objective:
- To determine the safety, time to treatment failure and survival in control and genotypic arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: docetaxel/gemcitabine |
| 2 | Active comparator | Drug: Docetaxel/DDP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- histologically confirmed non-small cell lung cancer (squamous cell carcinoma, large cells or adenocarcinoma; it is recommended to provide the full paraffin-embedded block or at least 5 5 sections obtained from the primary tumor, recurrence or metastasis, not stained, fixed in formalin/embedded in paraffin, mounted on slides (10 micron sections), as well as two serum samples in two 10-ml tubes and two blood samples (see appendix X);
- unresectable metastatic (stage IV or IIIB malignant pleural effusion) NSCLC;
- WHO performance status < 2;
- Adequate bone marrow, hepatic and renal functions, assessed during the previous 14 days, that should be shown by the following characteristics:
- at least one measurable lesion;
Key exclusion criteria (18 listed)
- pregnant or lactating women (women of childbearing potential must use adequate contraception);
- prior systemic chemotherapy or immunotherapy for NSCLC, even as neoadjuvant or adjuvant therapy;
- prior malignancies, except cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with non-evidence of disease for at least 5 years;
- history or clinical symptomatic brain or leptomeningeal metastases;
- current peripheral neuropathy and neurohearing > or = NCIC-CTG grade 2 except if due to trauma;
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/DDP | Drug | 2 |
| docetaxel/gemcitabine | Drug | 1 |
Primary outcome
Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.
3 secondary outcomes
Time to treatment failure and survival
Time frame: calculated from the registration date until progression or death, respectively
Clinical and laboratory toxicities graded according to NCIC-CTG Expanded Common Toxicity Criteria.
Time frame: before each cycle
Adverse events not reported in NCIC-CTG Expanded Common Toxicity Criteria will be graded as mild, moderate, severe, and life threatening.
Time frame: Throughout 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 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.
Jean-Philippe Aussel study director
Sanofi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel/DDP and docetaxel/gemcitabine in people with Lung Neoplasms, run by Sanofi at 3 sites in 3 countries.
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 24 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 3 sites in Germany, Spain, Switzerland. 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 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 response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.. 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.