Phase II Study of Paclitaxel Plus Carboplatin in Recurrent and/or Metastatic Cervical Carcinoma

Abstract

Objective To assess the therapeutic efficacy and toxicities of paclitaxel and carboplatin in
treatment of recurrent and/or metastatic cervical carcinoma.
Design Phase II trial.
Setting Multicenters.
Subjects and Method Between December 1997 and April 1999, 32 patients with recurrent and/
or metastatic cervical cancer were treated with paclitaxel 175 mg/m2 and carboplatin at AUC 5
every 3 weeks for 6 cycles.
Main outcome Response rate, drug toxicity, time to progression and survival.
Results Paclitaxel 175 mg./m 2 plus carboplatin AUC 5 achieved overall response rate of
62.6% with 31.3% complete response and 31.3% partial response. The median progression
free survival was 26.86 weeks and median survival was 58.57 weeks. The major toxicities
were hematologic toxicity with 13.8% of grade 3 and 4 leucopenia, 48.3% grade 3 anemia and
3.5% of grade 3 thrombocytopenia. Overall, the toxicities were moderate and manageable with
no serious adverse effect.
Conclusion Paclitaxel and carboplatin achieved promising response in recurrent and metastatic
cervical carcinona with modest toxicity. Phase III randomized trial on this combination should
be performed to confirm the efficacy of this regimen.