Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
Information source: Windy Hill Medical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ductal Carcinoma In Situ
Intervention: Carboplatin i.d. Days 1 & 15 (Drug); Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 (Drug); Normal Saline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Windy Hill Medical, Inc. Official(s) and/or principal investigator(s): Jane Doerr, RN, MSN, Study Director, Affiliation: Windy Hill Medical, Inc.
Overall contact: Jane Doerr, RN, MSN, Phone: 949-636-4737, Email: jdoerr@whmed.com
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.
Clinical Details
Official title: A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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: characterize i.d. carboplatin pharmacokineticscharacterize clinical extent of disease on MRI and/or mammogram characterize the histopathological assessment of DCIS 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Jane Doerr, RN, MSN, Phone: 949-636-4737, Email: jdoerr@whmed.com
OU Medical Center Laboratory, Oklahoma City, Oklahoma 73104, United States; Recruiting William C Dooley, M.D., F.A.C.S., Phone: 405-206-5670, Email: William-Dooley@ouhsc.edu Linda White, R.N., Phone: (949) 300-9576, Email: lwhite@whmed.com
MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting Henry Kuerer, M.D., Phone: 713-745-5043, Email: lboehnke@mdanderson.org Linda White, R.N., Phone: 949 300-9576, Email: lwhite@whmed.com
Additional Information
Related 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.
Starting date: May 2008
Last updated: October 1, 2008
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