Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

NCT00022022 | Unknown Phase 3

• 3 other identifiers: CDR0000068702ITA-INTN-DISTALEU-20103
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 16

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Quality of life

• Toxicity

• Response rate

• Time to progression

• Survival

Interventions

docetaxel DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Istituto Nazionale per lo Studio e la Cura dei Tumori: lead

Study Sites (16)

Istituto Di Ricovero E Cura A Carattere Scientifico

Bari, 70126, Italy

Location

Azienda Ospedaliena G. Rummo

Benevento, 82100, Italy

Location

Ospedale Cardarelli - Campobasso

Campobasso, Italy

Location

Ospedale Civile Cosenza

Cosenza, 87100, Italy

Location

Ospedale San Giuseppe

Milan, 20153, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Ospedale San Paolo

Milan, 20142, Italy

Location

Federico II University Medical School

Naples, 80131, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Ospedale Vincenzo Monaldi

Naples, 80131, Italy

Location

Seconda Universita di Napoli

Naples, 80133, Italy

Location

Ospedale Civile P.F. Calvi

Noale, Italy

Location

Azienda Ospedaliera Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Ospedale La Maddalena - Palermo

Palermo, Italy

Location

Ospedale San Carlo

Potenza, 85100, Italy

Location

Ospedale da Procida

Salerno, Italy

Location

Related 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. doi: 10.1200/JCO.2006.09.8251.

  PMID: 17416857 BACKGROUND

• 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.

  PMID: 15558071 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Cesare Gridelli, MD

  Istituto Nazionale per lo Studio e la Cura dei Tumori

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: December 1, 2000
• Last Updated: December 18, 2013

Record last verified: 2006-04

Locations

IT (16)