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

Phase 3

Terminated

• Conditions: Advanced Non-Small Cell Lung Cancer
• Interventions: Drug: docetaxel; Drug: capecitabine; Drug: vinorelbine; Drug: gemcitabine

• Registration Number: NCT00345059
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-06-26
• Study First Submitted QC: 2006-06-26
• Study First Posted: 2006-06-27
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
docetaxel + capecitabine	capecitabine	docetaxel in combination with capecitabine
docetaxel + vinorelbine OR gemcitabine	docetaxel	docetaxel in combination with either vinorelbine or with gemcitabine
docetaxel	docetaxel	single agent docetaxel
docetaxel + vinorelbine OR gemcitabine	vinorelbine	docetaxel in combination with either vinorelbine or with gemcitabine
docetaxel + vinorelbine OR gemcitabine	gemcitabine	docetaxel in combination with either vinorelbine or with gemcitabine
docetaxel + capecitabine	docetaxel	docetaxel in combination with capecitabine

Primary Outcome Measures

Name	Time	Method
overall survival	one year

Trial Locations

Locations (24)

Ospedali Riuniti; 🇮🇹 Foggia, FG, Italy

Ospedale Civile di Legnano; 🇮🇹 Legnano, MI, Italy

Ospedale S. Paolo; 🇮🇹 Milano, MI, Italy

Azienda Ospedaliera Di Busto Arsizio; 🇮🇹 Saronno, VA, Italy

Università di Chieti; 🇮🇹 Chieti, CH, Italy

Ospedale Fatebenefratelli, U.O. di Oncologia; 🇮🇹 Benevento, BN, Italy

Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano; 🇮🇹 Cuggiono, MI, Italy

Ospedale di Gaeta; 🇮🇹 Gaeta, LT, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, PD, Italy

Presidio Ospedaliaro Alto Gardo e Ledro; 🇮🇹 Arco, TN, Italy

U.L.S.S. 15 Regione Veneto; 🇮🇹 Cittadella, PD, Italy

Azienda Ospedaliera V. Cervello; 🇮🇹 Palermo, PA, Italy

Azienda Ospedaliera Giovanni Paolo II; 🇮🇹 Sciacca, AG, Italy

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica; 🇮🇹 Monteforte Irpino, AV, Italy

Azienda Ospedaliera G. Rummo; 🇮🇹 Benevento, BN, Italy

Ospedale S. Gerado; 🇮🇹 Monza, MI, Italy

Ospedale E. Morelli; 🇮🇹 Sondalo, SO, Italy

Divisione di Oncologia Medica, U.S.L.L. 13; 🇮🇹 Noale, VE, Italy

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B; 🇮🇹 Napoli, Italy

Ospedale Umberto di Frosinone; 🇮🇹 Frosinone, FR, Italy

Ospedale Buccheri La Ferla - Fatebenefratelli; 🇮🇹 Palermo, PA, Italy

Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia; 🇮🇹 Mantova, MN, Italy

Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, SI, Italy

Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico; 🇮🇹 Palermo, PA, Italy