Paclitaxel, Carboplatin, and Gefitinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel and carboplatin together with gefitinib may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and carboplatin together with gefitinib and to see how well it works in treating patients with Stage IIIB or stage IV non-small cell lung cancer.

Detailed Description
-----------------
OBJECTIVES: Primary To determine the efficacy, in terms of overall response, and safety of paclitaxel and carboplatin in combination with intermittent gefitinib in patients with advanced nonsquamous non-small cell lung cancer. Secondary Determine the disease-control rate in patients treated with this regimen. Determine the quality of life of patients treated with this regimen. Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: Patients receive paclitaxel IV on day 1, carboplatin IV on day 2, and oral gefitinib once daily on days 8-17. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with complete response or partial response may continue maintenance therapy comprising oral gefitinib once daily in the absence of disease progression or unacceptable toxicity. Patients complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline, during study treatment, and after completion of study treatment for quality-of-life study. After completion of study treatment, patients are followed every 2 months for 2 years and then every 4 months thereafter.

Official Title
-----------------
Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: carboplatin
* Drug: gefitinib
* Drug: paclitaxel
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) No squamous cell carcinoma Untreated Stage IIIB or IV disease not suitable for surgery or radiotherapy OR patients with postoperative recurrence who had never been treated by chemotherapy No history of smoking or light smoking (< 10 packs a year and smoking abatement ≥ 15 years) At least 1 measurable tumor mass (length > 1.5 cm and width > 1.0 cm) No symptomatic brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0-1 Absolute neutrophil count ≥ 2 x 10^9/L Platelet count ≥ 100 x 10^9/L ALT and AST ≤ 1.5 times upper limit of normal (ULN) Total bilirubin ≤1.5 times ULN Serum creatinine normal Creatinine clearance ≥ 50 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignant tumors within the past year except for basal cell or squamous cell carcinoma of the skin, or in situ malignant cancer that has been completely resected No history of allergic reaction to any component of the drugs in this study PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 1 month since prior investigational drugs or medical devices No prior chemotherapy or radiotherapy for this tumor No concurrent liposomal paclitaxel No other concurrent antitumor therapy (e.g., radiotherapy or surgical treatment) No other concurrent anticancer chemotherapy drugs or anticancer Chinese herbs

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: gefitinib|nan|
|Drug: paclitaxel|nan|
|Procedure: quality-of-life assessment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall-response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-control rate |  |  | 
| Safety |  |  | 
| Quality of life |  |  | 
| Progression-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer