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The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer (DISTAL-2)

Primary Purpose

Advanced Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
docetaxel
vinorelbine
gemcitabine
capecitabine
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-Small Cell Lung Cancer focused on measuring second line, monochemotherapy, combination chemotherapy, platinum refractory, previously treated

Eligibility Criteria

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

Inclusion Criteria: Written informed consent Age > 18 Histological diagnosis of non small-cell lung cancer (NSCLC) Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion) Disease in progression Previous chemotherapy with platinum-derivative (and with > 21 days from last administration) Exclusion Criteria: ECOG performance status > 2 Age > 75 years History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated) Previous treatment with docetaxel Presence of symptomatic cerebral metastasis Neutrophils < 2.0 x 109/l, platelets < 100,000/l, hemoglobin > 10g/dl Bilirubin < 1.5 x the upper normal limit SGOT , SGPT, or bilirubin > 1.25 x the upper normal limits except in the presence of hepatic metastasis Creatinine >1.25 x the upper normal limit Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol Inability to comply with follow up Pregnant or nursing females

Sites / Locations

  • Azienda Ospedaliera Giovanni Paolo II
  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
  • Ospedale Fatebenefratelli, U.O. di Oncologia
  • Azienda Ospedaliera G. Rummo
  • Università di Chieti
  • Ospedali Riuniti
  • Ospedale Umberto di Frosinone
  • Ospedale di Gaeta
  • Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano
  • Ospedale Civile di Legnano
  • Ospedale S. Paolo
  • Ospedale S. Gerado
  • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
  • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
  • Azienda Ospedaliera V. Cervello
  • Ospedale Buccheri La Ferla - Fatebenefratelli
  • U.L.S.S. 15 Regione Veneto
  • Istituto Oncologico Veneto
  • Azienda Ospedaliera Universitaria Senese
  • Ospedale E. Morelli
  • Presidio Ospedaliaro Alto Gardo e Ledro
  • Azienda Ospedaliera Di Busto Arsizio
  • Divisione di Oncologia Medica, U.S.L.L. 13
  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

docetaxel

docetaxel + vinorelbine OR gemcitabine

docetaxel + capecitabine

Arm Description

single agent docetaxel

docetaxel in combination with either vinorelbine or with gemcitabine

docetaxel in combination with capecitabine

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Full Information

First Posted
June 26, 2006
Last Updated
January 13, 2016
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00345059
Brief Title
The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
Acronym
DISTAL-2
Official Title
Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.
Detailed Description
This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens: docetaxel docetaxel + vinorelbine docetaxel + gemcitabine docetaxel + capecitabine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-Small Cell Lung Cancer
Keywords
second line, monochemotherapy, combination chemotherapy, platinum refractory, previously treated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
docetaxel
Arm Type
Active Comparator
Arm Description
single agent docetaxel
Arm Title
docetaxel + vinorelbine OR gemcitabine
Arm Type
Experimental
Arm Description
docetaxel in combination with either vinorelbine or with gemcitabine
Arm Title
docetaxel + capecitabine
Arm Type
Experimental
Arm Description
docetaxel in combination with capecitabine
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Type
Drug
Intervention Name(s)
capecitabine
Primary Outcome Measure Information:
Title
overall survival
Time Frame
one year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Age > 18 Histological diagnosis of non small-cell lung cancer (NSCLC) Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion) Disease in progression Previous chemotherapy with platinum-derivative (and with > 21 days from last administration) Exclusion Criteria: ECOG performance status > 2 Age > 75 years History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated) Previous treatment with docetaxel Presence of symptomatic cerebral metastasis Neutrophils < 2.0 x 109/l, platelets < 100,000/l, hemoglobin > 10g/dl Bilirubin < 1.5 x the upper normal limit SGOT , SGPT, or bilirubin > 1.25 x the upper normal limits except in the presence of hepatic metastasis Creatinine >1.25 x the upper normal limit Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol Inability to comply with follow up Pregnant or nursing females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Gridelli, M.D.
Organizational Affiliation
S.G. Moscati Hospital, Avellino, Italy; Division of Medical Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples Italy; Director Clinical Trials Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ciro Gallo, M.D., Ph.D.
Organizational Affiliation
Second University of Naples, Italy; Chair Medical Statistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Giovanni Paolo II
City
Sciacca
State/Province
AG
Country
Italy
Facility Name
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
City
Monteforte Irpino
State/Province
AV
ZIP/Postal Code
83024
Country
Italy
Facility Name
Ospedale Fatebenefratelli, U.O. di Oncologia
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Azienda Ospedaliera G. Rummo
City
Benevento
State/Province
BN
Country
Italy
Facility Name
Università di Chieti
City
Chieti
State/Province
CH
ZIP/Postal Code
66013
Country
Italy
Facility Name
Ospedali Riuniti
City
Foggia
State/Province
FG
Country
Italy
Facility Name
Ospedale Umberto di Frosinone
City
Frosinone
State/Province
FR
ZIP/Postal Code
03031
Country
Italy
Facility Name
Ospedale di Gaeta
City
Gaeta
State/Province
LT
ZIP/Postal Code
04024
Country
Italy
Facility Name
Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano
City
Cuggiono
State/Province
MI
Country
Italy
Facility Name
Ospedale Civile di Legnano
City
Legnano
State/Province
MI
Country
Italy
Facility Name
Ospedale S. Paolo
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
Facility Name
Ospedale S. Gerado
City
Monza
State/Province
MI
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
City
Mantova
State/Province
MN
ZIP/Postal Code
46100
Country
Italy
Facility Name
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliera V. Cervello
City
Palermo
State/Province
PA
Country
Italy
Facility Name
Ospedale Buccheri La Ferla - Fatebenefratelli
City
Palermo
State/Province
PA
Country
Italy
Facility Name
U.L.S.S. 15 Regione Veneto
City
Cittadella
State/Province
PD
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
State/Province
PD
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
State/Province
SI
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ospedale E. Morelli
City
Sondalo
State/Province
SO
ZIP/Postal Code
23039
Country
Italy
Facility Name
Presidio Ospedaliaro Alto Gardo e Ledro
City
Arco
State/Province
TN
ZIP/Postal Code
38062
Country
Italy
Facility Name
Azienda Ospedaliera Di Busto Arsizio
City
Saronno
State/Province
VA
ZIP/Postal Code
21047
Country
Italy
Facility Name
Divisione di Oncologia Medica, U.S.L.L. 13
City
Noale
State/Province
VE
ZIP/Postal Code
30033
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Citations:
Citation
Gebbia V, Morena R, Frontini L, Aitini E, Daniele B, Gamucci T, Di Maio M, Morabito A, Gallo C, Gridelli C. The DISTAL-2 phase III randomized trial of single agent weekly docetaxel (wD) vs wD plus gemcitabine (G) or vinorelbine (V) vs wD plus capecitabine (X) as second-line treatment of advanced non-small-cell lung cancer (NSCLC) patients (pts). J Clin Oncol 26: 2008 (May 20 suppl; abstr 19057)
Results Reference
result
PubMed Identifier
18632181
Citation
Gebbia V, Gridelli C, Verusio C, Frontini L, Aitini E, Daniele B, Gamucci T, Mancuso G, Di Maio M, Gallo C, Perrone F, Morabito A. Weekly docetaxel vs. docetaxel-based combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer patients. The DISTAL-2 randomized trial. Lung Cancer. 2009 Feb;63(2):251-8. doi: 10.1016/j.lungcan.2008.05.027. Epub 2008 Jul 15.
Results Reference
result

Learn more about this trial

The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

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