Phase II Study of Docetaxel, Carboplatin and 5FU in Recurrent Cancer of the Cervix
Background: Standard chemotherapy for recurrent cancer of the cervix is
still platinum based. The toxicity profile of cisplatin and the availability of
less toxic platinum analogues has encouraged its replacement by
carboplatin in clinical trials and the desire for higher survival benefit
continues to fuel the search for more effective combinations. The current
phase II study assessed docetaxel with carboplatin and 5-Fluorouracil
given weekly for 24 weeks, for recurrent cancer of the uterine cervix.
Methods: Forty patients with histologically confirmed, recurrent uterine
cervix cancer were enrolled. The patients eligible for this study had
histologically confirmed recurrent uterine cervix cancer. Patients received
weekly docetaxel 20 mg/m2 and carboplatin area under the curve (AUC2)
weekly with bolus 5FU 500 mg/m2. The response status of the patients
was assessed using the common ECOG response criteria.
Results: 40 patients were entered in this study. The distribution of intial
stage at first presentation was IB, 6; IIB, 16; IIIB, 10; IVB, 8. There were
30 squamous cell carcinomas, 6 adenocarcinomas, 4 adenosquamous cell
carcinoma. : All patients were evaluable, and completed all planned
therapy. The most frequent maximum toxicities during chemotherapy were
Grade 2 mucositis with neutopenia. Nonhematological toxicity was
generally mild, except for ubiquitous complete alopecia. Responses after 6
months included 6 patients with complete responses, 22 patients with
Partial response (PR) and 12 patients with Stable disease (SD). No
progression of disease was observed.
Conclusions: This regimen was feasible, safe, and particularly well
tolerated. Early Phase II outcomes revealed promising activity in patients
completing all treatment.
Key words: Cancer, Cervix, Docetaxel, Recurrent.