NCT00345059

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Typical duration for phase_3

Geographic Reach
1 country

24 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

3 years

First QC Date

June 26, 2006

Last Update Submit

January 13, 2016

Conditions

Advanced Non-Small Cell Lung Cancer

Keywords

second linemonochemotherapycombination chemotherapyplatinum refractorypreviously treated

Outcome Measures

Primary Outcomes (1)

  • overall survival

    one year

Study Arms (3)

docetaxel

ACTIVE COMPARATOR

single agent docetaxel

Drug: docetaxel

docetaxel + vinorelbine OR gemcitabine

EXPERIMENTAL

docetaxel in combination with either vinorelbine or with gemcitabine

Drug: docetaxelDrug: vinorelbineDrug: gemcitabine

docetaxel + capecitabine

EXPERIMENTAL

docetaxel in combination with capecitabine

Drug: docetaxelDrug: capecitabine

Interventions

docetaxelDRUG
docetaxeldocetaxel + capecitabinedocetaxel + vinorelbine OR gemcitabine
vinorelbineDRUG
docetaxel + vinorelbine OR gemcitabine
gemcitabineDRUG
docetaxel + vinorelbine OR gemcitabine
capecitabineDRUG
docetaxel + capecitabine

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Azienda Ospedaliera Giovanni Paolo II

Sciacca, AG, Italy

Location

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

Monteforte Irpino, AV, 83024, Italy

Location

Ospedale Fatebenefratelli, U.O. di Oncologia

Benevento, BN, 82100, Italy

Location

Azienda Ospedaliera G. Rummo

Benevento, BN, Italy

Location

Università di Chieti

Chieti, CH, 66013, Italy

Location

Ospedali Riuniti

Foggia, FG, Italy

Location

Ospedale Umberto di Frosinone

Frosinone, FR, 03031, Italy

Location

Ospedale di Gaeta

Gaeta, LT, 04024, Italy

Location

Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano

Cuggiono, MI, Italy

Location

Ospedale Civile di Legnano

Legnano, MI, Italy

Location

Ospedale S. Paolo

Milan, MI, 20142, Italy

Location

Ospedale S. Gerado

Monza, MI, 20052, Italy

Location

Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia

Mantova, MN, 46100, Italy

Location

Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico

Palermo, PA, 90146, Italy

Location

Azienda Ospedaliera V. Cervello

Palermo, PA, Italy

Location

Ospedale Buccheri La Ferla - Fatebenefratelli

Palermo, PA, Italy

Location

U.L.S.S. 15 Regione Veneto

Cittadella, PD, Italy

Location

Istituto Oncologico Veneto

Padua, PD, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, SI, 53100, Italy

Location

Ospedale E. Morelli

Sondalo, SO, 23039, Italy

Location

Presidio Ospedaliaro Alto Gardo e Ledro

Arco, TN, 38062, Italy

Location

Azienda Ospedaliera Di Busto Arsizio

Saronno, VA, 21047, Italy

Location

Divisione di Oncologia Medica, U.S.L.L. 13

Noale, VE, 30033, Italy

Location

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, 80131, Italy

Location

Related Publications (2)

  • 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)

    RESULT

  • 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.

    PMID: 18632181RESULT

MeSH Terms

Interventions

DocetaxelVinorelbineGemcitabineCapecitabine

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Cesare Gridelli, M.D.

    S.G. Moscati Hospital, Avellino, Italy; Division of Medical Oncology

    PRINCIPAL INVESTIGATOR

  • Francesco Perrone, M.D., Ph.D

    National Cancer Institute, Naples Italy; Director Clinical Trials Unit

    PRINCIPAL INVESTIGATOR

  • Ciro Gallo, M.D., Ph.D.

    Second University of Naples, Italy; Chair Medical Statistics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 27, 2006

Study Start

May 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

IT(24)