Phase I-II study of combination chemotherapy with Irinotecan and Gemcitabine for taxane/platinum resistant ovarian, fallopian tube or primary peritoneal cancer - Phase I-II study of Irinotecan and Gemcitabine for recurrent ovarian cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
PURPOSE: To develop a new therapeutic strategy for taxane/platinum-resistant/refractory ovarian and primary peritoneal cancers, we evaluated the feasibility and efficacy of irinotecan and gemcitabine combination chemotherapy. METHODS: Patients with taxane/platinum-resistant/refractory cancer received escalating doses of irinotecan and gemcitabine (level 1: 80 and 800 mg/m2, respectively; level 2: 100 and 1000 mg/m2) on days 1 and 8 on a 21-day cycle. Genotyping for UGT1A1*6 and 28 polymorphisms was performed for possible adverse irinotecan sensitivity. RESULTS: A total of 35 patients were enrolled. The recommended dose was defined as 100 mg/m2 irinotecan and 1000 mg/m2 gemcitabine (level 2). The observed common grade 3/4 toxicities were neutropenia (60%), anemia (17.1%), diarrhea (8.6%), thrombocytopenia (5.7%) and nausea (5.7%). Groups homozygous for UGT1A16 or *28 were associated with grade 3/4 neutropenia and diarrhea. Objective responses were 20%, including one complete response and six partial responses. In 29 patients treated with the recommended dose, the median progression-free survival and overall survival were 3.8 months (95% CI 2.1-6.0 months) and 17.4 months (95% CI 9.9-21.9 months), respectively, while the 1-year survival rate was 58.6%. CONCLUSIONS: Combination chemotherapy with irinotecan and gemcitabine represents a safe and effective treatment combination for taxane/platinum-resistant/refractory ovarian and primary peritoneal cancers.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1)Patients who have a history of severe hypersensitivity to drug. 2)Patients with interstitial pneumonia. 3)Patients who have mmasive ascites and/or pleural effusion. 4)Patients who have severe infectious diseases. 5)Patients with other malignant disease. 6)Women at pregnant state or possibly pregnant women. 7)Patients with mental diseases. 8)Patients with symptomatic brain metastasis. 9)Patients with severe coronary disease. 10) Patients with uncontrollable diabetic disease. 11)Patients with watery diarrhea. 12)Patients with severe ileus. 13)Patients with intestinal bleeding. 14)Patients with positeve HBs antigen. 15)Patients with severe medical complications. 16)Patients with systematic edema. 17)Patients who are considered inappropriate for this study by the doctor.