Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer

Study Overview
=================
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.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).

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 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.

Official Title
-----------------
A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.

Conditions
-----------------
Non Small Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: Gemcitabine
* Drug: Taxol


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: Gemcitabine|nan|
|Drug: Taxol|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-Complete response |  |  | 
| 2-Partial response |  |  | 
| 3-Stable disease |  |  | 
| 4-Progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Toxicity (NCI-CTC criteria) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non small cell lung carcinoma, Cisplatin, Gemcitabine, Paclitaxel