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Phase I trial of bi-weekly docetaxel combined with carboplatin for patients with non-small cell lung cancer.

7241 Background: Docetaxel (D) combined with carboplatin (C) is widely used regimen for advanced non-small cell lung cancer (NSCLC). We conducted this trial to determine the maximum tolerated dose (MTD) of bi-weekly D combined with C and to assess toxicities of this regimen.


METHODS
Histologically proven chemotherapy-naïve NSCLC patients were entered to this study. Other entry criteria were (1) age equal or less than 75, (2) ECOG PS 0-1, (3) WBC ≥ 4000, Neut ≥ 2000, Plts ≥ 100000, Hb ≥ 9.0, GOT, GPT ≤ 1.5 upper limit, Ccr ≥ 40, PaO2 ≥ 60, (4) life expectancy more than 3 months, and (5) written informed consent. C was administered on day 1 and D was administered on day 1 and 15 every 4 weeks. Doses of agents were planned to increase from level 1 (C: AUC 5.0, D: 30 mg/m2) to level 2 (C: AUC 5.0, D: 35 mg/m2) and level 3 (C: AUC 6.0, D: 35 mg/m2). The level where dose limiting toxicities (DLT) such as Grade 4 neutropenia lasting for 4 days, needs for platelet transfusion, Grade 3 or more non-hematological toxicities were observed in 3/3 or 3/6 or more patients was determined as MTD.


RESULTS
Ten patients were enrolled in this study. No patient experienced DLT in each level. Hematological toxicities were moderate and no neutropenic fever was observed (Table). Non-hematological toxicities were also mild and no Grade 3/4 non-hematological toxicities were observed. Two patients experienced Grade 2 vertigo and another patient suffered from Grade 2 infection. Overall response rate was 20 % (2/10).


CONCLUSIONS
Bi-weekly D combined with C may be effective for NSCLC with quite moderate toxicities. We are now conducting a phase II trial of this regimen. [Figure: see text] No significant financial relationships to disclose.