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

October 1, 2008 updated by: Windy Hill Medical, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Medical Center Laboratory
        • Contact:
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Carboplatin infused into DCIS-involved duct on Days 1 & 15
Drug: Carboplatin i.d. Days 1 & 15
Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 & 15
Other Names:
  • Paraplatin
EXPERIMENTAL: B
Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 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
Other Names:
  • Paraplatin
PLACEBO_COMPARATOR: C
Normal Saline infused into DCIS-involved duct Days 1 & 15
Drug: Normal Saline
Normal Saline, 10 ml, i.d. on Days 1 and 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 to 4 weeks following the Day 15 intraductal infusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Windy Hill Medical, Inc.

Investigators

  • Study Director: Jane Doerr, RN, MSN, Windy Hill Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ANTICIPATED)

September 1, 2009

Study Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (ESTIMATE)

April 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2008

Last Update Submitted That Met QC Criteria

October 1, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIS-WHM-703M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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