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A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ductal Carcinoma In Situ

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Trial Information

A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 to 4 weeks following the Day 15 intraductal infusion

Safety Issue:

Yes

Principal Investigator

Jane Doerr, RN, MSN

Investigator Role:

Study Director

Investigator Affiliation:

Windy Hill Medical, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

DCIS-WHM-703M

NCT ID:

NCT00669747

Start Date:

May 2008

Completion Date:

December 2009

Related Keywords:

  • Ductal Carcinoma In Situ
  • Ductal Carcinoma In Situ
  • DCIS
  • Breast Cancer
  • Carboplatin
  • Intraductal
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
OU Medical Center Laboratory Oklahoma City, Oklahoma  73104