Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

NCT ID: NCT00022022

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

docetaxel

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Nazionale per lo Studio e la Cura dei Tumori

OTHER

Sponsor Role: lead

Principal Investigators

Cesare Gridelli, MD

Role: STUDY_CHAIR

Istituto Nazionale per lo Studio e la Cura dei Tumori

Locations

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 San Giuseppe

Milan, , Italy

Ospedale Luigi Sacco

Milan, , Italy

Ospedale San Paolo

Milan, , 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, , Italy

Countries

Italy

References

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. doi: 10.1200/JCO.2006.09.8251.

Reference Type: BACKGROUND

PMID: 17416857 (View on PubMed)

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 regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study. Br J Cancer. 2004 Dec 13;91(12):1996-2004. doi: 10.1038/sj.bjc.6602241.

Reference Type: RESULT

PMID: 15558071 (View on PubMed)

Other Identifiers

ITA-INTN-DISTAL

Identifier Type: -

Identifier Source: secondary_id

EU-20103

Identifier Type: -

Identifier Source: secondary_id

CDR0000068702

Identifier Type: -

Identifier Source: org_study_id