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

Windy Hill Medical

Status and phase: Unknown; Phase 2

Conditions: Ductal Carcinoma In Situ

Treatments: Drug: Carboplatin i.d. Days 1 & 15; Drug: Normal Saline; Drug: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15

Study type: Interventional

Funder types: Industry

Identifiers

NCT00669747

DCIS-WHM-703M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

Carboplatin infused into DCIS-involved duct on Days 1 \& 15

Treatment:

Drug: Carboplatin i.d. Days 1 & 15

B

Experimental group

Description:

Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15

Treatment:

Drug: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15

C

Placebo Comparator group

Description:

Normal Saline infused into DCIS-involved duct Days 1 \& 15

Treatment:

Drug: Normal Saline