Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
1 other identifier
interventional
45
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 30, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 2, 2008
October 1, 2008
1.3 years
April 28, 2008
October 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
2 to 4 weeks following the Day 15 intraductal infusion
Secondary Outcomes (4)
characterize i.d. carboplatin pharmacokinetics
4 -8 weeks
characterize clinical extent of disease on MRI and/or mammogram
2 - 4 weeks
characterize the histopathological assessment of DCIS
4 - 10 weeks
Biomarker measurement of Ki-67, TUNEL and G-actin
4 - 8 weeks
Study Arms (3)
A
EXPERIMENTALCarboplatin infused into DCIS-involved duct on Days 1 \& 15
B
EXPERIMENTALCarboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15
C
PLACEBO COMPARATORNormal Saline infused into DCIS-involved duct Days 1 \& 15
Interventions
Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 \& 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
Eligibility Criteria
You may qualify if:
- Female
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
OU Medical Center Laboratory
Oklahoma City, Oklahoma, 73104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (3)
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.
PMID: 15382093BACKGROUNDLi 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.
PMID: 15824180BACKGROUNDKhan 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.
PMID: 15494601BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jane Doerr, RN, MSN
Windy Hill Medical, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 28, 2008
First Posted
April 30, 2008
Study Start
May 1, 2008
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
October 2, 2008
Record last verified: 2008-10