Gynecologic oncology · 2004
A phase II trial of capecitabine in heavily pre-treated platinum-resistant ovarian cancer.
Клиническое исследованиеКлиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Rischin Danny, Phillips Kelly-Anne, Friedlander Michael, Harnett Paul, Quinn Michael, Richardson Gary, Martin Andrew
Аннотация
OBJECTIVE: To determine the activity of capecitabine in women with platinum-resistant ovarian cancer.
METHODS: In this multi-centre phase II trial, 35 patients with platinum-resistant ovarian, primary peritoneal or fallopian tube carcinomas were treated with capecitabine 1250 mg/m(2) twice daily for 14 days every 21 days. Platinum resistance was defined as progression within 4 months of completing the last platinum and all patients had previously received a taxane. Response was assessed by both RECIST criteria for patients with measurable disease and CA125 criteria. Responders were defined as patients with measurable disease who achieved a CR or PR according to RECIST criteria, patients without measurable disease who met the CA125 criteria for response and patients with stable measurable disease who met the CA125 criteria for response.
RESULTS: Patients had received a median of four prior chemotherapy regimens (range 1-9). The median number of cycles of capecitabine administered was 3 (range 1-10). The response rate using the combined RECIST and CA125 criteria was 9% (95% CI 2-25%). In patients evaluable using RECIST criteria, the response rate was 5% (95% CI 0-25%). In patients evaluable for CA125 response, the response rate was 7% (95% CI 1-22%). The median progression-free survival was 2.3 months, and the median survival was 7.1 months. Treatment was generally well tolerated with most frequent grade 3 toxicities being hand-foot syndrome (17%) and diarrhea (9%).
CONCLUSION: Capecitabine is well tolerated but has limited activity in patients with heavily pre-treated platinum-resistant ovarian cancer.
METHODS: In this multi-centre phase II trial, 35 patients with platinum-resistant ovarian, primary peritoneal or fallopian tube carcinomas were treated with capecitabine 1250 mg/m(2) twice daily for 14 days every 21 days. Platinum resistance was defined as progression within 4 months of completing the last platinum and all patients had previously received a taxane. Response was assessed by both RECIST criteria for patients with measurable disease and CA125 criteria. Responders were defined as patients with measurable disease who achieved a CR or PR according to RECIST criteria, patients without measurable disease who met the CA125 criteria for response and patients with stable measurable disease who met the CA125 criteria for response.
RESULTS: Patients had received a median of four prior chemotherapy regimens (range 1-9). The median number of cycles of capecitabine administered was 3 (range 1-10). The response rate using the combined RECIST and CA125 criteria was 9% (95% CI 2-25%). In patients evaluable using RECIST criteria, the response rate was 5% (95% CI 0-25%). In patients evaluable for CA125 response, the response rate was 7% (95% CI 1-22%). The median progression-free survival was 2.3 months, and the median survival was 7.1 months. Treatment was generally well tolerated with most frequent grade 3 toxicities being hand-foot syndrome (17%) and diarrhea (9%).
CONCLUSION: Capecitabine is well tolerated but has limited activity in patients with heavily pre-treated platinum-resistant ovarian cancer.