Clinical Trial: Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ

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 Summary:

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.


Sponsor: Windy Hill Medical, Inc.

Current Primary Outcome: 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 [ Time Frame: 2 to 4 weeks following the Day 15 intraductal infusion ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • characterize i.d. carboplatin pharmacokinetics [ Time Frame: 4 -8 weeks ]
  • characterize clinical extent of disease on MRI and/or mammogram [ Time Frame: 2 - 4 weeks ]
  • characterize the histopathological assessment of DCIS [ Time Frame: 4 - 10 weeks ]
  • Biomarker measurement of Ki-67, TUNEL and G-actin [ Time Frame: 4 - 8 weeks ]


Original Secondary Outcome: Same as current

Information By: Windy Hill Medical, Inc.

Dates:
Date Received: April 28, 2008
Date Started: May 2008
Date Completion: December 2009
Last Updated: October 1, 2008
Last Verified: October 2008