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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345059
Recruitment Status : Terminated (slow accrual)
First Posted : June 27, 2006
Last Update Posted : January 14, 2016
Information provided by (Responsible Party):
National Cancer Institute, Naples

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.

Condition or disease Intervention/treatment Phase
Advanced Non-Small Cell Lung Cancer Drug: docetaxel Drug: vinorelbine Drug: gemcitabine Drug: capecitabine Phase 3

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  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer
Study Start Date : May 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

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: vinorelbine
Drug: gemcitabine
Experimental: docetaxel + capecitabine
docetaxel in combination with capecitabine
Drug: docetaxel
Drug: capecitabine

Primary Outcome Measures :
  1. overall survival [ Time Frame: one year ]

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345059

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

Responsible Party: National Cancer Institute, Naples Identifier: NCT00345059     History of Changes
Other Study ID Numbers: DISTAL-2
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by National Cancer Institute, Naples:
second line
combination chemotherapy
platinum refractory
previously treated

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic