Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00022022
• Other study ID #: CDR0000068702
• Secondary ID: ITA-INTN-DISTALE
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 10, 2001
• Last updated: December 17, 2013
• Start date: December 2000

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• docetaxel

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
Italy	Istituto Di Ricovero E Cura A Carattere Scientifico	Bari
Italy	Azienda Ospedaliena G. Rummo	Benevento
Italy	Ospedale Cardarelli - Campobasso	Campobasso
Italy	Ospedale Civile Cosenza	Cosenza
Italy	Ospedale Luigi Sacco	Milan
Italy	Ospedale San Giuseppe	Milan
Italy	Ospedale San Paolo	Milano
Italy	Federico II University Medical School	Naples
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples
Italy	Ospedale Vincenzo Monaldi	Naples
Italy	Seconda Universita di Napoli	Naples
Italy	Ospedale Civile P.F. Calvi	Noale
Italy	Azienda Ospedaliera Policlinico Paolo Giaccone	Palermo
Italy	Ospedale La Maddalena - Palermo	Palermo
Italy	Ospedale San Carlo	Potenza
Italy	Ospedale da Procida	Salerno

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Nazionale per lo Studio e la Cura dei Tumori

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2007 Apr 10;25(11):1377-82. — View Citation

Gridelli C, Gallo C, Di Maio M, Barletta E, Illiano A, Maione P, Salvagni S, Piantedosi FV, Palazzolo G, Caffo O, Ceribelli A, Falcone A, Mazzanti P, Brancaccio L, Capuano MA, Isa L, Barbera S, Perrone F. A randomised clinical trial of two docetaxel regim — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life			No
Primary	Toxicity			Yes
Primary	Response rate			No
Primary	Time to progression			No
Primary	Survival			No