Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Windy Hill Medical, Inc.
• Treatments: Carboplatin

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