Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
NCT ID: NCT00669747
Last Updated: 2008-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2008-05-31
2009-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Carboplatin infused into DCIS-involved duct on Days 1 \& 15
Carboplatin i.d. Days 1 & 15
Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 \& 15
B
Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15
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
C
Normal Saline infused into DCIS-involved duct Days 1 \& 15
Normal Saline
Normal Saline, 10 ml, i.d. on Days 1 and 15
Interventions
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Carboplatin i.d. Days 1 & 15
Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 \& 15
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
Normal Saline
Normal Saline, 10 ml, i.d. on Days 1 and 15
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Windy Hill Medical, Inc.
INDUSTRY
Responsible Party
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Windy Hill Medical, Inc.
Principal Investigators
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Jane Doerr, RN, MSN
Role: STUDY_DIRECTOR
Windy Hill Medical, Inc.
Locations
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OU Medical Center Laboratory
Oklahoma City, Oklahoma, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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William C Dooley, M.D., F.A.C.S.
Role: primary
Linda White, R.N.
Role: backup
Henry Kuerer, M.D.
Role: primary
Linda White, R.N.
Role: backup
References
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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.
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.
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.
Other Identifiers
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DCIS-WHM-703M
Identifier Type: -
Identifier Source: org_study_id