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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Ductal Carcinoma In Situ	Drug: Carboplatin i.d. Days 1 & 15; Drug: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15; Drug: Normal Saline	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
Study Start Date :	May 2008
Estimated Primary Completion Date :	September 2009
Estimated Study Completion Date :	December 2009

Arms and Interventions

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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 Name: 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 Name: 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

Outcome Measures

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Primary Outcome Measures :

1. 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 Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Contacts

Contact: Jane Doerr, RN, MSN	949-636-4737	jdoerr@whmed.com
Contact: Andy Dorr, MD	949-584-4975	andy.dorr@whmed.com

Locations

United States, Oklahoma
OU Medical Center Laboratory	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: William C Dooley, M.D., F.A.C.S. 405-206-5670 William-Dooley@ouhsc.edu
Contact: Linda White, R.N. (949) 300-9576 lwhite@whmed.com
United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Henry Kuerer, M.D. 713-745-5043 lboehnke@mdanderson.org
Contact: Linda White, R.N. 949 300-9576 lwhite@whmed.com

Sponsors and Collaborators

Windy Hill Medical, Inc.

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Love SM, Barsky SH. Anatomy of the nipple and breast ducts revisited. Cancer. 2004 Nov 1;101(9):1947-57.

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.

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.

Responsible Party:	Windy Hill Medical, Inc. (Ms. Jane Doerr, R.N., Director of Clinical Development), Windy Hill Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00669747 History of Changes
Other Study ID Numbers:	DCIS-WHM-703M
First Posted:	April 30, 2008
Last Update Posted:	October 2, 2008
Last Verified:	October 2008

Keywords provided by Windy Hill Medical, Inc.:

Ductal Carcinoma In Situ; DCIS; Breast Cancer; Carboplatin; Intraductal

Additional relevant MeSH terms:

Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type	Neoplasms; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carboplatin; Antineoplastic Agents