Status:
COMPLETED
Pharmaco-economic Study of a Second Line Treatment in Advanced Non Small Cell Lung Cancer
Lead Sponsor:
University Hospital, Limoges
Collaborating Sponsors:
Groupe Francais De Pneumo-Cancerologie
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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). E...
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 pati...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00284778
Start Date
February 1 2006
End Date
December 1 2009
Last Update
July 24 2025
Active Locations (18)
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1
Service de Pneumologie, CHU Angers
Angers, France, 49033
2
Service de pneumologie; Centre Hospitalier d'Annecy
Annecy, France, 74011
3
Service de Pneumologie; Centre Hospitalier
Beauvais, France, 60 021
4
Service de Pneumologie ; Centre hospitalier
Charleville-Mézières, France, 08 000