Open, randomized, phase II study of single-agent gemcitabine and docetaxel as first- and second-line treatment in patients with advanced non-small-cell lung cancer.

Background: Chemotherapy has been widely accepted as standard for palliation in advanced non-small-cell lung cancer. Gemcitabine and docetaxel are active as single agents. Our previous experience indicates that single-agent therapy, if given sequentially, could be an alternative to doublet combination chemotherapy and that sequence and schedule matter.

Randomized multicenter phase II study of gemcitabine versus docetaxel as first-line therapy with second-line crossover in advanced-stage non-small-cell lung cancer.

Background: A randomized phase II study was performed to determine whether single-agent gemcitabine or docetaxel with the introduction of the opposite agent in case of disease progression (ie, in the second-line setting) is feasible and effective in chemotherapy-naive patients with advanced non-small-cell lung cancer (NSCLC).

Patients And Methods: The doses were 1,000 mg/m2 for gemcitabine and 35 mg/m2 for docetaxel, each given on days 1, 8, and 15 every 4 weeks. After a planned interim analysis, the docetaxel/gemcitabine arm (ie, docetaxel followed by gemcitabine) was closed after enrollment of 49 patients because of poor predefined feasibility.

Long-term survival in SCLC after treatment with paclitaxel, carboplatin and etoposide--a phase II study.

Purpose: We evaluated the toxicity and feasibility of adding paclitaxel to a standard platinum/etoposide regimen in the first-line treatment of patients with small cell lung cancer (SCLC).

Patients And Methods: Eighty-nine patients with limited disease (LD) or extensive disease without distant metastases (ED I) were treated in this multi-centered phase II trial between April 1996 and June 1997. Paclitaxel administration (175 mg/m(2) by a 1 h intravenous infusion) was immediately followed by a 30 min infusion of carboplatin at an area under the concentration time curve (AUC) of 5 on day 1 and etoposide 50 mg orally twice daily (bid) was given on days 2-8.