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

NCT00669747 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2008-10-02

No results posted yet for this study

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.

Conditions

  • Ductal Carcinoma In Situ

Interventions

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

Sponsors & Collaborators

  • Windy Hill Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Jane Doerr, RN, MSN · Windy Hill Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669747 on ClinicalTrials.gov