A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.
18 Years
70 Years
Both
Non Small Cell Lung Carcinoma
Trial Information
A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.
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 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent
cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2
d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and
paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with
dose decrease if needed). Response criteria are assessed with RECIST classification by the
investigator panel.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1-Complete response
Principal Investigator
Alain Vergnengre, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Limoges
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
I03022
NCT ID:
NCT00199758
Start Date:
September 2003
Completion Date:
June 2007
Related Keywords:
- Non Small Cell Lung Carcinoma
- Non small cell lung carcinoma
- Cisplatin
- Gemcitabine
- Paclitaxel
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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