A Phase I/II Study of Docetaxel and Gemcitabine Combination for Chemotherapy-resistant Ovarian Cancer

Background: A phase I/II study of docetaxel (DOC) and gemcitabine (GEM) combination for treatment-resistant ovarian cancer (OC) was conducted. Materials and Methods: Eligible patients exhibited recurrent OC within 12 months after initial treatment, or after more than 2 chemotherapy regimens. Planned dose levels (DL) were as follows: DOC 70 mg/m 2 , GEM 800 mg/m 2 (DL1); DOC 70 mg/m 2 , GEM 1000 mg/m 2 (DL2). DOC was administered on day 1 combined with GEM on days 1 and 8 every 3 weeks. Adverse events were assessed by NCI-CTC2.0J. Response was evaluated by RECIST or Rustin's criteria. Results: The recommended dose was DL1. For all enrolled patients, the median interval from last chemotherapy was 2.5 ( 1 - 11 ) months and 32 patients were assessable for response. One complete response, 6 partial responses and 6 stable disease were noted. Median time to progression was 4.8 months. Toxicities were mainly hematological and manageable. Conclusion: This combination could be an acceptable treatment option before palliation.