Pharmaco-economic Study of a Second Line Treatment in Advanced Non Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Collaborator: Groupe Francais De Pneumo-Cancerologie
• Treatments: Docetaxel; Pemetrexed

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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