A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
Jane Doerr, RN, MSN
Windy Hill Medical, Inc.
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|OU Medical Center Laboratory||Oklahoma City, Oklahoma 73104|