Status:
COMPLETED
Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
Lead Sponsor:
University Hospital, Limoges
Collaborating Sponsors:
Groupe Francais De Pneumo-Cancerologie
Conditions:
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Acc...
Detailed Description
Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 ...
Eligibility Criteria
Inclusion
- Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
- Metastatic relapses allowed in not irradiated area.
- Age between 18 and 70 years
- Chemonaïve patients
- At least one measurable target lesion according to recist criteria in non previously irradiated area.
- Performance status \< 2
- Normal hepatic and renal function, absolute neutrophil count \>1,5 giga/l, platelets \>100 giga/l.
- Written informed consent.
- Life expectancy \> 12 weeks.
Exclusion
- SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
- Previous chemotherapeutic treatment.
- Symptomatic brain metastases.
- Superior vena cava syndrome.
- Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
- Peripheral neuropathy grade ≥2.
- Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
- Hypersensitivity to paclitaxel or polysorbate 80.
- Pregnancy or breast feeding.
- Any concomitant radiotherapy, except palliative bone irradiation.
- Follow-up of the patient impossible.
- Prisoners.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00199758
Start Date
September 1 2003
End Date
June 1 2007
Last Update
July 16 2025
Active Locations (21)
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1
Service de Pneumologie
Beauvais, France
2
Service de Pneumologie
Bordeaux, France
3
Service de Pneumologie
Charleville Mezière, France
4
Service de Pneumologie
Créteil, France