Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00022022
- Lead Sponsor
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy.
* Compare the toxicity of these regimens in these patients.
* Compare the response rate, time to progression, and survival of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a maximum of 6 courses.
* Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8 weeks for a maximum of 2 courses.
Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life Toxicity Response rate Time to progression Survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Istituto Di Ricovero E Cura A Carattere Scientifico
🇮🇹Bari, Italy
Ospedale San Paolo
🇮🇹Milano, Italy
Ospedale Luigi Sacco
🇮🇹Milan, Italy
Ospedale Vincenzo Monaldi
🇮🇹Naples, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples, Italy
Azienda Ospedaliena G. Rummo
🇮🇹Benevento, Italy
Ospedale Civile Cosenza
🇮🇹Cosenza, Italy
Ospedale San Giuseppe
🇮🇹Milan, Italy
Federico II University Medical School
🇮🇹Naples, Italy
Ospedale Civile P.F. Calvi
🇮🇹Noale, Italy
Azienda Ospedaliera Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Ospedale San Carlo
🇮🇹Potenza, Italy
Ospedale Cardarelli - Campobasso
🇮🇹Campobasso, Italy
Seconda Universita di Napoli
🇮🇹Naples, Italy
Ospedale da Procida
🇮🇹Salerno, Italy
Ospedale La Maddalena - Palermo
🇮🇹Palermo, Italy