Abstract
BACKGROUND
The authors administered a combination of docetaxel and topotecan with granulocyte–colony‐stimulating factor (G‐CSF) support in a Phase I study to define the maximum tolerated dose (MTD) of this regimen.
METHODS
Patients with advanced‐stage solid tumors were eligible for this trial if they had a Zubrod performance status of ≤ 2 and normal renal, hepatic, and bone marrow function. No previous therapy with taxanes or topoisomerase inhibitors was allowed. The authors administered both docetaxel and topotecan in a dose‐escalated manner until the MTD was reached. Docetaxel was given on Day 1 of each cycle before topotecan, which was administered intravenously on Days 1–3. Granulocyte–colony‐stimulating factor (G‐CSF) support with 5 μg/kg subcutaneous injections was initiated on Day 4 and continued until the absolute granulocyte count recovered to 2000/μL. Treatment cycles were repeated every 21 days.
RESULTS
Of the 11 patients enrolled in the current study, all were evaluable for toxicity and 10 were evaluable for response. A median of three treatment cycles was received (range, one to nine treatment cycles). The dose‐limiting toxicity was Grade 4 (according to the National Cancer Institute Common Toxicity Criteria for Adverse Events [version 2.0]). neutropenia with fever. The MTD was 75 mg/m^2^ of docetaxel on Day 1 and 1.4 mg/m^2^ of topotecan on Days 1–3. There was one complete response and one partial response in patients with nasopharyngeal carcinoma and one partial response in a patient with small cell lung carcinoma (SCLC). The response durations were 24 weeks, 29 weeks, and ≥ 244 weeks, respectively. At the time of last follow‐up, both patients with nasopharyngeal carcinoma were still alive at 241 weeks and 244 weeks, respectively.
CONCLUSIONS
This trial demonstrated that a regimen of docetaxel and topotecan with G‐CSF support was generally well tolerated and had promising activity in patients with nasopharyngeal and SCLC. Cancer 2004. © 2004 American Cancer Society.