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.

Condition	Treatment or Intervention	Phase
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer Quality of Life	Drug: docetaxel  Procedure: chemotherapy  Procedure: quality-of-life assessment  Procedure: supportive care/therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
• Metastatic supraclavicular lymphadenopathy or malignant pleural effusion
• Progressive disease
• Must have received prior chemotherapy
• No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age:

• 18 to 75

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 1.25 times ULN

Renal:

• Creatinine no greater than 1.25 times ULN

Cardiovascular:

• No prior or concurrent cardiovascular disease that would preclude study

Pulmonary:

• See Disease Characteristics
• No prior or concurrent pulmonary disease that would preclude study

Other:

• No prior or other concurrent illness or medical condition that would preclude study
• No other prior malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• No prior docetaxel
• At least 3 weeks since other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy allowed
• No concurrent radiotherapy

Surgery:

• Prior radical surgery for NSCLC allowed
• Concurrent palliative surgery allowed

Italy
      Azienda Ospedaliena G. Rummo, Benevento,  82100,  Italy; Recruiting
      Federico II University Medical School, Naples,  80131,  Italy; Recruiting
      Istituto Di Ricovero E Cura A Carattere Scientifico, Bari,  70126,  Italy; Recruiting
      Istituto Di Science Biomediche San Paolo, Milano,  20142,  Italy; Recruiting
      Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples,  80131,  Italy; Recruiting
      Ospedale Cardarelli - Campobasso, Campobasso,  Italy; Recruiting
      Ospedale Civile Cosenza, Cosenza,  87100,  Italy; Recruiting
      Ospedale Civile P.F. Calvi, Noale,  Italy; Recruiting
      Ospedale da Procida, Salerno,  Italy; Recruiting
      Ospedale La Maddalena - Palermo, Palermo,  Italy; Recruiting
      Ospedale Luigi Sacco, Milan,  20157,  Italy; Recruiting
      Ospedale San Carlo, Potenza,  85100,  Italy; Recruiting
      Ospedale San Giuseppe, Milan,  20153,  Italy; Recruiting
      Ospedale Vincenzo Monaldi, Naples,  80131,  Italy; Recruiting
      Policlinico P. Giaccone - Universita Di Palermo, Palermo,  90127,  Italy; Recruiting
      Seconda Universita di Napoli, Naples,  80133,  Italy; Recruiting

Study chairs or principal investigators

Cesare Gridelli, MD,  Study Chair,  Istituto Nazionale per lo Studio e la Cura dei Tumori   

Study ID Numbers:  CDR0000068702; ITA-INTN-DISTAL; EU-20103; NCT00022022
Record last reviewed:  August 2001
Last Updated:  February 4, 2005
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022022
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08