Clinical trial NCT00345059: The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
Official title: Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Advanced Non-Small Cell Lung Cancer
Keywords: second line
monochemotherapy
combination chemotherapy
platinum refractory
previously treated
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 84
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: overall survival
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sciacca
country: Italy
facility: Azienda Ospedaliera Giovanni Paolo II
state: AG
city: Monteforte Irpino
country: Italy
facility: Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
state: AV
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli, U.O. di Oncologia
state: BN
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
state: BN
city: Chieti
country: Italy
facility: Università di Chieti
state: CH
city: Foggia
country: Italy
facility: Ospedali Riuniti
state: FG
city: Frosinone
country: Italy
facility: Ospedale Umberto di Frosinone
state: FR
city: Gaeta
country: Italy
facility: Ospedale di Gaeta
state: LT
city: Cuggiono
country: Italy
facility: Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano
state: MI
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano
state: MI
city: Milano
country: Italy
facility: Ospedale S. Paolo
state: MI
city: Monza
country: Italy
facility: Ospedale S. Gerado
state: MI
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
state: MN
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
state: PA
city: Palermo
country: Italy
facility: Azienda Ospedaliera V. Cervello
state: PA
city: Palermo
country: Italy
facility: Ospedale Buccheri La Ferla - Fatebenefratelli
state: PA
city: Cittadella
country: Italy
facility: U.L.S.S. 15 Regione Veneto
state: PD
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
state: SI
city: Sondalo
country: Italy
facility: Ospedale E. Morelli
state: SO
city: Arco
country: Italy
facility: Presidio Ospedaliaro Alto Gardo e Ledro
state: TN
city: Saronno
country: Italy
facility: Azienda Ospedaliera Di Busto Arsizio
state: VA
city: Noale
country: Italy
facility: Divisione di Oncologia Medica, U.S.L.L. 13
state: VE
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Study officials:
affiliation: S.G. Moscati Hospital, Avellino, Italy; Division of Medical Oncology
name: Cesare Gridelli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples Italy; Director Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Second University of Naples, Italy; Chair Medical Statistics
name: Ciro Gallo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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)
citation: 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.