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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00345059
First received: June 26, 2006
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Advanced Non-Small Cell Lung Cancer
Drug: docetaxel
Drug: vinorelbine
Drug: gemcitabine
Drug: capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: May 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345059

Locations
Italy
Azienda Ospedaliera Giovanni Paolo II
Sciacca, AG, Italy
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
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
Azienda Ospedaliera V. Cervello
Palermo, PA, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, Italy, 90146
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
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
  More Information

Publications:
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
ClinicalTrials.gov Identifier: NCT00345059     History of Changes
Other Study ID Numbers: DISTAL-2
Study First Received: June 26, 2006
Last Updated: July 27, 2012
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014