A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion
研究概览
简要总结
The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion. Secondary objectives are to characterize the biologic and clinical effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram, histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.
详细描述
This is a randomized, 3-arm, saline-controlled study involving women undergoing surgical management of DCIS. Forty-five (45) women who have been diagnosed with DCIS by core biopsy will receive intraductal administration of either carboplatin or normal saline (NS) into the DCIS-involved breast duct. Thirty (30) patients (i.e., 15 patients per arm) will receive two intraductal infusions of either 100 mg of carboplatin or NS on Days 1 and 15. Fifteen (15) patients will receive an intraductal infusion of 100 mg carboplatin on Day 1 and an intraductal infusion of NS on Day 15. Patients will undergo surgical resection 2 to 4 weeks following the Day 15 intraductal infusion (i.e. 4 to 6 weeks from diagnosis).
The effect of carboplatin on DCIS in the pre-treatment core biopsy specimen and the resection specimen will be assessed. Venous blood samples will be collected for carboplatin PK analysis pre-dose and at 30 minutes, 1, 2, 4, and 8 hours following intraductal infusions on Days 1 and 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Scheduled to undergo surgical resection in 2 weeks or longer
- •Pathological diagnosis of DCIS requiring surgical resection
- •DCIS diagnosed with core biopsy
- •Mammogram within 6 weeks of diagnosis
- •Adequate organ function as defined by the following criteria:
- •Absolute neutrophil count (ANC) ≥ 1500/μl, Platelets ≥ 140,000/μl,Hemoglobin ≥ 12.0 g/dl, Creatinine < 2.0 mg/dl
- •Able to sign informed consent
排除标准
- •Current diagnosis of invasive or inflammatory breast carcinoma
- •DCIS with microinvasion on histology on core needle biopsy
- •Palpable mass
- •Mass on mammography
- •Concurrent anti-cancer therapy
- •Prior exposure to carboplatin (related to current or past diagnosis)
- •Prior radiation to the breast or chest wall
- •Prior areolar or breast surgery which interrupts communication of the ductal systems with the nipple
- •Presence of breast implants
- •Presence of ulcerating or fungal skin lesions or infection of the breasts
- •Pregnant or lactating
- •Impaired cardiac function or history of cardiac problems
- •Poor nutritional state (as determined by clinician)
- •Presence of serious infection
- •Scheduled for intraoperative radiation of breast or chest wall
- •Allergies to lidocaine or marcaine
- •Allergies to imaging dyes
研究组 & 干预措施
A
Carboplatin infused into DCIS-involved duct on Days 1 & 15
干预措施: Carboplatin i.d. Days 1 & 15 (Drug)
B
Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15
干预措施: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 (Drug)
C
Normal Saline infused into DCIS-involved duct Days 1 & 15
干预措施: Normal Saline (Drug)
结局指标
主要结局
Compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion
时间窗: 2 to 4 weeks following the Day 15 intraductal infusion
次要结局
- characterize the histopathological assessment of DCIS(4 - 10 weeks)
- Biomarker measurement of Ki-67, TUNEL and G-actin(4 - 8 weeks)
- characterize clinical extent of disease on MRI and/or mammogram(2 - 4 weeks)
- characterize i.d. carboplatin pharmacokinetics(4 -8 weeks)