NCT00669747

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Windy Hill Medical, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ductal Carcinoma In Situ

Interventions

Type	Name	Description
DRUG	Carboplatin i.d. Days 1 & 15	Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 \& 15
DRUG	Carboplatin i.d. Day 1; Normal Saline i.d. Day 15	Carboplatin 10 mg/ml, 10 ml (100 mg) i.d. DCIS duct on Day 1 Normal Saline, 10 ml i.d. DCIS duct on Day 15
DRUG	Normal Saline	Normal Saline, 10 ml, i.d. on Days 1 and 15

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2008-04-30
• Last updated: 2008-10-02

Locations

2 sites across 1 country: United States