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

Primary Purpose

Ductal Carcinoma In Situ

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin i.d. Days 1 & 15
Carboplatin i.d. Day 1; Normal Saline i.d. Day 15
Normal Saline
Sponsored by
Windy Hill Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductal Carcinoma In Situ focused on measuring Ductal Carcinoma In Situ, DCIS, Breast Cancer, Carboplatin, Intraductal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • OU Medical Center LaboratoryRecruiting
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Carboplatin infused into DCIS-involved duct on Days 1 & 15

Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15

Normal Saline infused into DCIS-involved duct Days 1 & 15

Outcomes

Primary Outcome Measures

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 Outcome Measures

characterize i.d. carboplatin pharmacokinetics
characterize clinical extent of disease on MRI and/or mammogram
characterize the histopathological assessment of DCIS
Biomarker measurement of Ki-67, TUNEL and G-actin

Full Information

First Posted
April 28, 2008
Last Updated
October 1, 2008
Sponsor
Windy Hill Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00669747
Brief Title
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
Official Title
A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Windy Hill Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma In Situ
Keywords
Ductal Carcinoma In Situ, DCIS, Breast Cancer, Carboplatin, Intraductal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Carboplatin infused into DCIS-involved duct on Days 1 & 15
Arm Title
B
Arm Type
Experimental
Arm Description
Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Normal Saline infused into DCIS-involved duct Days 1 & 15
Intervention Type
Drug
Intervention Name(s)
Carboplatin i.d. Days 1 & 15
Other Intervention Name(s)
Paraplatin
Intervention Description
Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 & 15
Intervention Type
Drug
Intervention Name(s)
Carboplatin i.d. Day 1; Normal Saline i.d. Day 15
Other Intervention Name(s)
Paraplatin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Normal Saline, 10 ml, i.d. on Days 1 and 15
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
characterize i.d. carboplatin pharmacokinetics
Time Frame
4 -8 weeks
Title
characterize clinical extent of disease on MRI and/or mammogram
Time Frame
2 - 4 weeks
Title
characterize the histopathological assessment of DCIS
Time Frame
4 - 10 weeks
Title
Biomarker measurement of Ki-67, TUNEL and G-actin
Time Frame
4 - 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Doerr, RN, MSN
Phone
949-636-4737
Email
jdoerr@whmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andy Dorr, MD
Phone
949-584-4975
Email
andy.dorr@whmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Doerr, RN, MSN
Organizational Affiliation
Windy Hill Medical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
OU Medical Center Laboratory
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William C Dooley, M.D., F.A.C.S.
Phone
405-206-5670
Email
William-Dooley@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Linda White, R.N.
Phone
(949) 300-9576
Email
lwhite@whmed.com
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Kuerer, M.D.
Phone
713-745-5043
Email
lboehnke@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Linda White, R.N.
Phone
949 300-9576
Email
lwhite@whmed.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
15382093
Citation
Love SM, Barsky SH. Anatomy of the nipple and breast ducts revisited. Cancer. 2004 Nov 1;101(9):1947-57. doi: 10.1002/cncr.20559.
Results Reference
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PubMed Identifier
15824180
Citation
Li CI, Daling JR, Malone KE. Age-specific incidence rates of in situ breast carcinomas by histologic type, 1980 to 2001. Cancer Epidemiol Biomarkers Prev. 2005 Apr;14(4):1008-11. doi: 10.1158/1055-9965.EPI-04-0849.
Results Reference
background
PubMed Identifier
15494601
Citation
Khan SA, Wiley EL, Rodriguez N, Baird C, Ramakrishnan R, Nayar R, Bryk M, Bethke KB, Staradub VL, Wolfman J, Rademaker A, Ljung BM, Morrow M. Ductal lavage findings in women with known breast cancer undergoing mastectomy. J Natl Cancer Inst. 2004 Oct 20;96(20):1510-7. doi: 10.1093/jnci/djh283.
Results Reference
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Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)

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