Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
Status unconfirmed · Phase 2
Conditions studied: Ductal Carcinoma In Situ
In brief
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.
Key facts
- Study ID
- NCT00669747
- Run by
- Windy Hill Medical, Inc.
- People needed
- 45
- Starts
- 2008-05-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2008-10-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
- Allergies to lidocaine or marcaine
- Allergies to imaging dyes
Where it is running
- OU Medical Center Laboratory — Oklahoma City, Oklahoma, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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