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

January 13, 2016 updated by: National Cancer Institute, Naples

Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
    • AG
      • Sciacca, AG, Italy
        • Azienda Ospedaliera Giovanni Paolo II
    • AV
      • Monteforte Irpino, AV, Italy, 83024
        • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
    • BN
      • Benevento, BN, Italy
        • Azienda Ospedaliera G. Rummo
      • Benevento, BN, Italy, 82100
        • Ospedale Fatebenefratelli, U.O. di Oncologia
    • CH
      • Chieti, CH, Italy, 66013
        • Università di Chieti
    • FG
      • Foggia, FG, Italy
        • Ospedali Riuniti
    • FR
      • Frosinone, FR, Italy, 03031
        • Ospedale Umberto di Frosinone
    • LT
      • Gaeta, LT, Italy, 04024
        • Ospedale di Gaeta
    • MI
      • Cuggiono, MI, Italy
        • Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano
      • Legnano, MI, Italy
        • Ospedale Civile di Legnano
      • Milano, MI, Italy, 20142
        • Ospedale S. Paolo
      • Monza, MI, Italy, 20052
        • Ospedale S. Gerado
    • MN
      • Mantova, MN, Italy, 46100
        • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
    • PA
      • Palermo, PA, Italy, 90146
        • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
      • Palermo, PA, Italy
        • Azienda Ospedaliera V. Cervello
      • Palermo, PA, Italy
        • Ospedale Buccheri La Ferla - Fatebenefratelli
    • PD
      • Cittadella, PD, Italy
        • U.L.S.S. 15 Regione Veneto
      • Padova, PD, Italy
        • Istituto Oncologico Veneto
    • SI
      • Siena, SI, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
    • SO
      • Sondalo, SO, Italy, 23039
        • Ospedale E. Morelli
    • TN
      • Arco, TN, Italy, 38062
        • Presidio Ospedaliaro Alto Gardo e Ledro
    • VA
      • Saronno, VA, Italy, 21047
        • Azienda Ospedaliera Di Busto Arsizio
    • VE
      • Noale, VE, Italy, 30033
        • Divisione di Oncologia Medica, U.S.L.L. 13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: docetaxel
single agent docetaxel
Drug: docetaxel
Experimental: docetaxel + vinorelbine OR gemcitabine
docetaxel in combination with either vinorelbine or with gemcitabine
Drug: docetaxel
Drug: gemcitabine
Drug: vinorelbine
Experimental: docetaxel + capecitabine
docetaxel in combination with capecitabine
Drug: docetaxel
Drug: capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISTAL-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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