The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
NCT ID: NCT00345059
Last Updated: 2016-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
84 participants
INTERVENTIONAL
2005-05-31
2008-05-31
Brief Summary
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Detailed Description
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* docetaxel
* docetaxel + vinorelbine
* docetaxel + gemcitabine
* docetaxel + capecitabine
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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docetaxel
single agent docetaxel
docetaxel
docetaxel + vinorelbine OR gemcitabine
docetaxel in combination with either vinorelbine or with gemcitabine
docetaxel
vinorelbine
gemcitabine
docetaxel + capecitabine
docetaxel in combination with capecitabine
docetaxel
capecitabine
Interventions
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docetaxel
vinorelbine
gemcitabine
capecitabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
75 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Cesare Gridelli, M.D.
Role: PRINCIPAL_INVESTIGATOR
S.G. Moscati Hospital, Avellino, Italy; Division of Medical Oncology
Francesco Perrone, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Second University of Naples, Italy; Chair Medical Statistics
Locations
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Azienda Ospedaliera Giovanni Paolo II
Sciacca, AG, Italy
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Università di Chieti
Chieti, CH, Italy
Ospedali Riuniti
Foggia, FG, Italy
Ospedale Umberto di Frosinone
Frosinone, FR, Italy
Ospedale di Gaeta
Gaeta, LT, Italy
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
Milan, MI, Italy
Ospedale S. Gerado
Monza, MI, Italy
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
Mantova, MN, Italy
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
Palermo, PA, Italy
U.L.S.S. 15 Regione Veneto
Cittadella, PD, Italy
Istituto Oncologico Veneto
Padua, PD, Italy
Azienda Ospedaliera Universitaria Senese
Siena, SI, Italy
Ospedale E. Morelli
Sondalo, SO, Italy
Presidio Ospedaliaro Alto Gardo e Ledro
Arco, TN, Italy
Azienda Ospedaliera Di Busto Arsizio
Saronno, VA, Italy
Divisione di Oncologia Medica, U.S.L.L. 13
Noale, VE, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, , Italy
Countries
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References
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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)
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.
Other Identifiers
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DISTAL-2
Identifier Type: -
Identifier Source: org_study_id
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