A phase II trial of docetaxel plus capecitabine in patients with previously treated non-small cell lung cancer.

Background: A combination of docetaxel (T) and capecitabine (X) showed synergistic effects in preclinical studies and phase III random zed trials of metastatic breast cancer. We conducted this phase 11 study to examine its efficacy in previously treated non-small cell lung cancer (NSCLC) patients. Methods: Patient eligibility required advanced NSCLC with measurable lesion(s), at least one prior regimen failure and Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Treatment consisted of T 36 mg/m(2) i.v. on days 1 and 8 plus X 1000 mg/m(2) p.o. b.i.d. on days 1-14 of a 21-day cycle (level 1) or T 30 mg/m(2) i.v. on days 1 and 8 plus X 625 mg/m(2) p.o. b.i.d. on days 1-14 of a 21-day cycle (level 11). Results: A total of 35 patients (M/F = 24/11) were enrolled; 29 had received one prior regimen and 19 had received platinum-based regimens. Significant non-hematologic toxicities were observed after the treatment given at level 1, including one treatment-related death. Subsequently 29 patients were treated at level II. The treatment at level 11 was well tolerated with grade 3 or 4 neutropenia only in 10%, grade 3 asthenia in 21% and stomatitis in 14% of patients. Four (15%) of 27 evaluable patients had partial response (PR) at level 11 and eight (30%) had stable disease (SD). Conclusions: The TX regimen showed modest antitumor effects in patients with previously treated NSCLC. For further studies, we recommer d T 30 mg/m(2) i.V. on days 1 and 8 plus X 625 mg/m(2) p.o. b.i.d. on days 1-14 of a 21-day cycle.