Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
- Conditions
- Ductal Carcinoma In Situ
- Interventions
- Registration Number
- NCT00669747
- Lead Sponsor
- Windy Hill Medical, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 45
- Female
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15 C Normal Saline Normal Saline infused into DCIS-involved duct Days 1 \& 15 A Carboplatin i.d. Days 1 & 15 Carboplatin infused into DCIS-involved duct on Days 1 \& 15
- Primary Outcome Measures
Name Time Method 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 2 to 4 weeks following the Day 15 intraductal infusion
- Secondary Outcome Measures
Name Time Method characterize the histopathological assessment of DCIS 4 - 10 weeks characterize clinical extent of disease on MRI and/or mammogram 2 - 4 weeks Biomarker measurement of Ki-67, TUNEL and G-actin 4 - 8 weeks characterize i.d. carboplatin pharmacokinetics 4 -8 weeks
Trial Locations
- Locations (2)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
OU Medical Center Laboratory
🇺🇸Oklahoma City, Oklahoma, United States