A phase II trial evaluating weekly docetaxel and capacitabine in patients with metastatic or advanced, locally, recurrent head and neck cancer

Abstract

6051 Background: Docetaxel has documented clinical efficacy in head and neck cancer and the synergy between docetaxel and capacitabine has been shown in preclinical studies. Phase I studies combining docetaxel and capacitabine demonstrated anti-tumor effects in breast, colon, and bladder cancers. We therefore test this combination in patients with metastatic or locally advanced head and neck cancer. Methods: To be eligible for this single arm safety/efficacy phase II study, patients must have documented measurable advanced, locally recurrent or metastatic head and neck cancers, which were untreatable by surgical resection or radiation therapy, a Zubrob performance status of 0–2, adequate marrow, hepatic and kidney functions. Prior chemotherapy with non-docetaxel containing regimen was allowed. Docetaxel 30 mg/m2 was given on day 1, 8 and 15, while capecitabine 1,000 mg bid was given on days 5–18 of the 28 days cycle. Response to treatment was assessed after every 2 cycles. Patients with complete response (CR) received 2 additional cycles of therapy. Patients with partial response (PR) or stable disease (SD) continued to receive the therapy until they developed CR or progressive disease (PD). Patients with PD or unacceptable toxicity will be off the study. Results: 39 patients (33 male, 6 female) with a median age of 58.4 years were enrolled between September 2003 and April 2008. At baseline, 14/39 patients (36%) had local regional disease, 17/39 (44%) had distant metastasis, and 7/39 (18%) had both. 31/39 (79%) of the patients had prior chemotherapy. Responses at 4 months were analyzed on 36 patients: 5 patients (13%) had confirmed responses (2 CR, 3 PR) and 8 patients (20%) had stable diseases. Progression-free survival at 6 month was 34% (95% CI 19% - 49%). Major grade 3 and 4 toxicities were lymphopenia (8/39, 20%), infection without neutropenia (5/39, 13%) and fatigue (4/39, 10%). Conclusions: Weekly docetaxel and capacitabine are well tolerated and the disease control rate (33%) is comparable with the historical controls in patients with metastatic or advanced, locally, recurrent head and neck cancers. No significant financial relationships to disclose.