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

Advanced Non-Small Cell Lung Cancer Clinical Trial

— DISTAL-2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00345059
• Other study ID #: DISTAL-2
• Status: Terminated
• Phase: Phase 3
• First received: June 26, 2006
• Last updated: January 13, 2016
• Start date: May 2005
• Est. completion date: May 2008

Study information

• Verified date: January 2016
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• docetaxel

• vinorelbine

• gemcitabine

• capecitabine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 cance — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		one year	No