Carcinoma, Non-Small-Cell LungPhase 3NCT00284778
Pharmaco-economic Study of a Second Line Treatment in Advanced Non Small Cell Lung Cancer
A Phase 3 study testing Alimta® and Taxotere® in people with Carcinoma, Non-Small-Cell Lung, run by University Hospital, Limoges at 18 sites in France.
Trial summary
The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature. 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?
- Alimta® and Taxotere®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 18 sitesFrance
- Study dates
- Feb 2006to Dec 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
- Metastatic relapses allowed if asymptomatic.
- Progressive disease during or after a standard first line platinum-based chemotherapy (without taxotere or alimta)
- Only one chemotherapeutic line including adjuvant and neo adjuvant treatment.
- Irradiation allowed if < 25% bone medulla . It may be ended 2 weeks before the second line treatment.
- At least one measurable target lesion according to recist criteria in non previously irradiated area.
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- Performance status <=2
- Age between 18 and 70 years
- Life expectancy > 12 weeks.
- Normal hepatic function
- Normal renal function
- Normal serum calcium
- Absolute neutrophil count>1.5 gigal/l,platelets>100 gigal/l,haemoglobin>9.0 g/dl
- Written informed consent
Who cannot join
- SCLC, bronchioli-alveolar and neuro-endocrine carcinoma.
- Symptomatic brain metastases.
- Superior vena cava syndrome.
- Uncontrolled fluid retention in the third space (pleural or ascitic collection)
- Prior chemotherapy without platin
- Other concomitant diseases: heart failure, angina pectoris, tachyarrythmia, recent myocardial infarction, active infections.
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- Peripheral neuropathy grade ≥ 2.
- Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
- Hypersensitivity to docetaxel or polysorbate 80.
- Unability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids.
- Pregnancy or breast feeding.
- Follow-up of the patient impossible.
- Prisoners
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Service de Pneumologie, CHU Angers
Angers, 49033
Service de pneumologie; Centre Hospitalier d'Annecy
Annecy, 74011
Service de Pneumologie; Centre Hospitalier
Beauvais, 60 021
Service de Pneumologie ; Centre hospitalier
Charleville-Mézières, 08 000
Service de Pneumologie; Centre Hospitalier
Draguignan, 83300
Service de Pathologie Respiratoire; CHU de Limoges
Limoges, 87000
Service de Pneumologie; Hôpital de la Croix Rousse
Lyon, 69317
Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay
Mantes-la-Jolie, 78200
Département des Maladies Respiratoires ; Hôpital Sainte Marguerite
Marseille, 13274
Service de Pneumologie et Réanimation ; Hôpital Hôtel Dieu - Paris
Paris, 75181
Service de Pneumologie - Hôpital St Antoine, Paris
Paris, 75571
Service de Pneumologie ; Hôpital saint Antoine, Paris
Paris
Service de Pneumologie-Allergologie; Centre Hospitalier Général
Périgueux, 24019
Service de Pneumologie; CHG de Roanne
Roanne, 42300
Clinique Pneumologique; Hôpital Charles Nicolle
Rouen, 76031
Service de Pneumologie; Hôpital Bois Guillaume
Rouen, 76233
Service d'Oncologie Médicale; Clinique Sainte Marguerite
Toulon, 83000
Service de Pathologie Respiratoire; Hôpital d'Instruction des Armées Sainte-Anne
Toulon Naval, 83800
About this study
Official title: A Randomized Cost-minimization Trial Comparing Pemetrexed (Alimta®) Versus Docetaxel (Taxotere®) as Second Line Treatment in Advanced Non Small Cell Lung Cancer (NSCLC): Study 05-06 of Groupe Français de Pneumo-Cancérologie (GFPC).
The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature.
Economic analyses are currently one of the criteria used in medical decision, beside effectiveness, quality of life and toxicities.
Read more
However, Economical comparison shows significant variations in the acquisition costs of the two drugs. Consequently, it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment.
As there is no difference in the effectiveness between the two treatments, a cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an economical point of view (payer).
Read the detailed description
The main objective of this trial is of to compare, economically, the use of pemetrexed (alimta®) in 2nd line chemotherapy in advanced non-small cell lung cancer versus docetaxel (taxotere®).
150 patients will be selected for this trial which, after checking the eligibility criteria, will be randomized in two arms:
- Arm A: Taxotere 75 mg/m² every 3 weeks.
- Arm B : Alimta 500 mg/m² every 3 weeks.
Inclusion assessment.
- Clinical signs
- Blood cell count, renal and hepatic function (within 8 days)
- Chest X ray, CT scan or MRI scan, abdominal echography, and/or abdominal scan (within 28 days)
- Brain scan, bone scintigraphy and/or bone x ray (within 28 days)
- Bronchial endoscopy (within 28 days)
- EKG, echocardiography according to history
Follow-up assessment.
- At each cycle
- Clinical signs
- Blood cell count at D1, D8, D15
- Creatinine, serum electrolytes (K+, Ca++ ), SGOT, SGPT, total bilirubin, LDH, alkaline phosphate, total protein and albumin, EKG, Chest X-ray at D1
- Follow-up each 2 months till PD
- End of trial: Complete tumor assessment
- Each objective response may be confirm 4 weeks later
Length ot the study.
- Patients in each arm will be treated until progression or toxicity or decision to stop the trial.
- Responder patient will be treated until 6 cycles. The follow-up assessment will be carried out each 2 months.
Response assessment. According to RECIST criteria.
Resource consumption.
- Recording of volumes:
- All the medication quantities will be recorded in mg. The chemotherapeutic products will be recorded in mg. All the concomitant treatments : RHO, anti-emetics, growth factors, antibiotics or adverse event treatments will be notified.
- Hospitalizations for treatment and their categories ( inpatient, outpatient, home based treatment) will be noted.
- All the hospitalizations for adverse events will be recorded (and their category). Grade 1-2 adverse events will be notified in the case report form. Hospitalizations for disease complications or progressions, curative or palliative radiation will be recorded.
- Cost calculation :
- All hospitalisations will be valued by DRGs or day hospitalisation prices, according to the country. Ambulatory care will be valued by appropriate country prices. The drug price will be done by pharmaceutical companies.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Alimta®, Taxotere®
- Keywords
- lung cancer, second line treatment, cost-minimization trial, Pharmaco-economic study, docetaxel, pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alimta®Drug
Taxotere®Drug
| Study group | Role | What they receive |
|---|---|---|
| ALIMTA | Experimental | Not described Receives: Drug: Alimta® |
| Docetaxe | Active comparator | Not described Receives: Drug: Taxotere® |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Francais De Pneumo-Cancerologie
- Responsible party
- Sponsor
- Investigators
- Alain Vergnenegre, MD, Principal investigator, CHU LimogesChristos Chouaid, MD, Study chair, Hôpital Saint Antoine; Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284778
- Sponsor's protocol ID
- I05026
- Status last verified
- Mar 2010
- First submitted
- 31 Jan 2006
- Last updated
- 24 Jul 2025
- Results posted
- No
Publications
Vergnenegre A, Corre R, Berard H, Paillotin D, Dujon C, Robinet G, Crequit J, Bota S, Thomas P, Chouaid C; 0506 GFPC Team. Cost-effectiveness of second-line chemotherapy for non-small cell lung cancer: an economic, randomized, prospective, multicenter phase III trial comparing docetaxel and pemetrexed: the GFPC 05-06 study. J Thorac Oncol. 2011 Jan;6(1):161-8. doi: 10.1097/JTO.0b013e318200f4c1.
PubMed 21150465
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cost-minimization Trial Comparing Pemetrexed (Alimta®) Versus Docetaxel (Taxotere®) as Second Line Treatment in Advanced Non Small Cell Lung Cancer (NSCLC): Study 05-06 of Groupe Français de Pneumo-Cancérologie (GFPC).
- ClinicalTrials.gov ID
- NCT00284778
- Acronym / sponsor ID
- I05026
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- lung cancer, second line treatment, cost-minimization trial, Pharmaco-economic study, docetaxel, pemetrexed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Groupe Francais De Pneumo-Cancerologie
- Study start
- Feb 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Feb 2006 (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 indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature.
Economic analyses are currently one of the criteria used in medical decision, beside effectiveness, quality of life and toxicities.
However, Economical comparison shows significant variations in the acquisition costs of the two drugs. Consequently, it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment.
As there is no difference in the effectiveness between the two treatments, a cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an economical point of view (payer).
Detailed description
The main objective of this trial is of to compare, economically, the use of pemetrexed (alimta®) in 2nd line chemotherapy in advanced non-small cell lung cancer versus docetaxel (taxotere®).
150 patients will be selected for this trial which, after checking the eligibility criteria, will be randomized in two arms:
- Arm A: Taxotere 75 mg/m² every 3 weeks.
- Arm B : Alimta 500 mg/m² every 3 weeks.
Inclusion assessment.
- Clinical signs
- Blood cell count, renal and hepatic function (within 8 days)
- Chest X ray, CT scan or MRI scan, abdominal echography, and/or abdominal scan (within 28 days)
- Brain scan, bone scintigraphy and/or bone x ray (within 28 days)
- Bronchial endoscopy (within 28 days)
- EKG, echocardiography according to history
Follow-up assessment.
- At each cycle
- Clinical signs
- Blood cell count at D1, D8, D15
- Creatinine, serum electrolytes (K+, Ca++ ), SGOT, SGPT, total bilirubin, LDH, alkaline phosphate, total protein and albumin, EKG, Chest X-ray at D1
- Follow-up each 2 months till PD
- End of trial: Complete tumor assessment
- Each objective response may be confirm 4 weeks later
Length ot the study.
- Patients in each arm will be treated until progression or toxicity or decision to stop the trial.
- Responder patient will be treated until 6 cycles. The follow-up assessment will be carried out each 2 months.
Response assessment. According to RECIST criteria.
Resource consumption.
- Recording of volumes:
- All the medication quantities will be recorded in mg. The chemotherapeutic products will be recorded in mg. All the concomitant treatments : RHO, anti-emetics, growth factors, antibiotics or adverse event treatments will be notified.
- Hospitalizations for treatment and their categories ( inpatient, outpatient, home based treatment) will be noted.
- All the hospitalizations for adverse events will be recorded (and their category). Grade 1-2 adverse events will be notified in the case report form. Hospitalizations for disease complications or progressions, curative or palliative radiation will be recorded.
- Cost calculation :
- All hospitalisations will be valued by DRGs or day hospitalisation prices, according to the country. Ambulatory care will be valued by appropriate country prices. The drug price will be done by pharmaceutical companies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALIMTA | Experimental | Drug: Alimta® |
| Docetaxe | Active comparator | Drug: Taxotere® |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
- Metastatic relapses allowed if asymptomatic.
- Progressive disease during or after a standard first line platinum-based chemotherapy (without taxotere or alimta)
- Only one chemotherapeutic line including adjuvant and neo adjuvant treatment.
- Irradiation allowed if < 25% bone medulla . It may be ended 2 weeks before the second line treatment.
Key exclusion criteria (13 listed)
- SCLC, bronchioli-alveolar and neuro-endocrine carcinoma.
- Symptomatic brain metastases.
- Superior vena cava syndrome.
- Uncontrolled fluid retention in the third space (pleural or ascitic collection)
- Prior chemotherapy without platin
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 |
|---|---|---|
| Alimta® | Drug | ALIMTA |
| Taxotere® | Drug | Docetaxe |
Primary outcome
Not reported in the source record.
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 24 Jul 2025.
- Results publication: PubMed 21150465Vergnenegre A, Corre R, Berard H, Paillotin D, Dujon C, Robinet G, Crequit J, Bota S, Thomas P, Chouaid C; 0506 GFPC Team. Cost-effectiveness of second-line chemotherapy for non-small cell lung cancer: an economic, randomized, prospective, multicenter phase III trial comparing docetaxel and pemetrexed: the GFPC 05-06 study. J Thorac Oncol. 2011 Jan;6(1):161-8. doi: 10.1097/JTO.0b013e318200f4c1.
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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.
Alain Vergnenegre, MD principal investigator
CHU Limoges
Christos Chouaid, MD study chair
Hôpital Saint Antoine; Paris
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alimta® and Taxotere® in people with Carcinoma, Non-Small-Cell Lung, run by University Hospital, Limoges at 18 sites in France.
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 14 inclusion and 13 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00284778, which also lists 1 linked publication.
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 24 Jul 2025.