NAPOLI-2: Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- The efficacy of fluorouracil, leucovorin, and nanoliposomal irinotecan in advanced biliary tract cancers following progression on or intolerance of gemcitabine and platinum chemotherapy.
研究概览
简要总结
This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.
详细描述
This is a single arm, open label, multicenter phase II study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy. Patients with advanced biliary tract cancers who have adequate performance status and adequate hepatic and renal function will be eligible. Patients may have received adjuvant chemotherapy and/or radiation therapy prior to enrolling in the trial, but a minimum of 6 months between adjuvant chemotherapy and this current therapy are required. Patients may continue on study as long as they are tolerating treatment and do not have progression of disease by RECIST v1.1 criteria. Response assessments will occur using imaging (CT or MRI) every 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic
- •Disease progression on or intolerance of gemcitabine- and platinum-based chemotherapy
- •No more than 1 prior line of chemotherapy for unresectable or metastatic disease (adjuvant therapy does not count)
- •Measurable disease by RECIST v1.1 criteria
- •ECOG performance status of 0-1
- •At least 18 years of age
- •HIV-positive patients are eligible provided: Stable HAART regimen, No concurrent prophylactic antibiotics or antifungals, and CD4 count above 250 and undetectable viral load
- •Adequate bone marrow, hepatic, and renal function
- •Consent to access archived tumor tissue if available (available tissue is not required for enrollment)
排除标准
- •Ampullary adenocarcinoma
- •Woman who are pregnant or breastfeeding
- •Anti-cancer treatment within 3 weeks prior to enrollment
- •Prior irinotecan or nanoliposomal irinotecan
- •Central nervous system metastases unless stable for at least 4 weeks and at least 2 weeks off corticosteroids
- •Exposure to a strong CYP3A4 inducer, strong CYP3A4 inhibitor, or strong UGT1A1 inhibitor within 2 weeks of study start
- •Known concurrent malignancy or other malignancy within 3 years except for non-melanomatous skin cancers, prostate or cervical cancers following curative therapy, or superficial bladder cancer
- •Bowel obstruction
- •Allergy or hypersensitivity to fluoropyrimidines, irinotecan, or nanoliposomal irinotecan
- •Clinically significant liver disease: Patients with resolved hepatitis B infection are eligible if HBsAg testing is negative; Patients with resolved hepatitis C infection are eligible if viral RNA PCR is negative
- •Severe infections within 4 weeks prior to enrollment
- •Major surgery within 4 weeks prior to enrollment
研究组 & 干预措施
Single Arm
Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days. Leucovorin 400 mg/ IV over 30 minutes, every 14 days. Fluorouracil 2,400 mg/m IV over 46 hours.
干预措施: Fluorouracil (Drug)
Single Arm
Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days. Leucovorin 400 mg/ IV over 30 minutes, every 14 days. Fluorouracil 2,400 mg/m IV over 46 hours.
干预措施: Nanoliposomal Irinotecan (Drug)
Single Arm
Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days. Leucovorin 400 mg/ IV over 30 minutes, every 14 days. Fluorouracil 2,400 mg/m IV over 46 hours.
干预措施: Leucovorin (Drug)
结局指标
主要结局
The efficacy of fluorouracil, leucovorin, and nanoliposomal irinotecan in advanced biliary tract cancers following progression on or intolerance of gemcitabine and platinum chemotherapy.
时间窗: 4 months
Defined as positive if there is no evidence of disease progression (PD) at 4 months, as measured by RECIST v1.1 criteria
次要结局
- Median time to disease progression (mTTP).(6 months)
- Disease control rate (DCR).(6 months)
- Overall response rate (ORR).(6 months)
- Median progression-free survival (mPFS).(6 months)
- Median overall survival (mOS).(6 months)
- Median duration of disease control (DDC).(6 months)
- Maximum change in tumor marker, CA19-9.(6 months)