Status:
UNKNOWN
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
Lead Sponsor:
Windy Hill Medical, Inc.
Conditions:
Ductal Carcinoma In Situ
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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) unde...
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 intradu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00669747
Start Date
May 1 2008
End Date
December 1 2009
Last Update
October 2 2008
Active Locations (2)
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1
OU Medical Center Laboratory
Oklahoma City, Oklahoma, United States, 73104
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030