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Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
docetaxel
quality-of-life assessment
Sponsored by
Istituto Nazionale per lo Studio e la Cura dei Tumori
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Di Ricovero E Cura A Carattere Scientifico
  • Azienda Ospedaliena G. Rummo
  • Ospedale Cardarelli - Campobasso
  • Ospedale Civile Cosenza
  • Ospedale San Paolo
  • Ospedale San Giuseppe
  • Ospedale Luigi Sacco
  • Federico II University Medical School
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Ospedale Vincenzo Monaldi
  • Seconda Universita di Napoli
  • Ospedale Civile P.F. Calvi
  • Azienda Ospedaliera Policlinico Paolo Giaccone
  • Ospedale La Maddalena - Palermo
  • Ospedale San Carlo
  • Ospedale da Procida

Outcomes

Primary Outcome Measures

Quality of life
Toxicity
Response rate
Time to progression
Survival

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
December 17, 2013
Sponsor
Istituto Nazionale per lo Studio e la Cura dei Tumori
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1. Study Identification

Unique Protocol Identification Number
NCT00022022
Brief Title
Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Official Title
Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Istituto Nazionale per lo Studio e la Cura dei Tumori

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Quality of life
Title
Toxicity
Title
Response rate
Title
Time to progression
Title
Survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Gridelli, MD
Organizational Affiliation
Istituto Nazionale per lo Studio e la Cura dei Tumori
Official's Role
Study Chair
Facility Information:
Facility Name
Istituto Di Ricovero E Cura A Carattere Scientifico
City
Bari
ZIP/Postal Code
70126
Country
Italy
Facility Name
Azienda Ospedaliena G. Rummo
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Ospedale Cardarelli - Campobasso
City
Campobasso
Country
Italy
Facility Name
Ospedale Civile Cosenza
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Facility Name
Ospedale San Paolo
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Ospedale San Giuseppe
City
Milan
ZIP/Postal Code
20153
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Federico II University Medical School
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Vincenzo Monaldi
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Seconda Universita di Napoli
City
Naples
ZIP/Postal Code
80133
Country
Italy
Facility Name
Ospedale Civile P.F. Calvi
City
Noale
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Ospedale La Maddalena - Palermo
City
Palermo
Country
Italy
Facility Name
Ospedale San Carlo
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Ospedale da Procida
City
Salerno
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17416857
Citation
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.
Results Reference
background
PubMed Identifier
15558071
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 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.
Results Reference
result

Learn more about this trial

Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

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