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

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Capecitabine; Docetaxel; Gemcitabine; Vinorelbine

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