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

Ductal Carcinoma In Situ Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00669747
• Other study ID #: DCIS-WHM-703M
• Status: Recruiting
• Phase: Phase 2
• First received: April 28, 2008
• Last updated: October 1, 2008
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2008
• Source: Windy Hill Medical, Inc.
• Contact: Jane Doerr, RN, MSN
• Phone: 949-636-4737
• Email: jdoerr[@]whmed.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma In Situ

Intervention

Drug:
• Carboplatin i.d. Days 1 & 15
Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 & 15
• Carboplatin i.d. Day 1; Normal Saline i.d. Day 15
Carboplatin 10 mg/ml, 10 ml (100 mg) i.d. DCIS duct on Day 1 Normal Saline, 10 ml i.d. DCIS duct on Day 15
• Normal Saline
Normal Saline, 10 ml, i.d. on Days 1 and 15

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	OU Medical Center Laboratory	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Windy Hill Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Khan SA, Wiley EL, Rodriguez N, Baird C, Ramakrishnan R, Nayar R, Bryk M, Bethke KB, Staradub VL, Wolfman J, Rademaker A, Ljung BM, Morrow M. Ductal lavage findings in women with known breast cancer undergoing mastectomy. J Natl Cancer Inst. 2004 Oct 20;96(20):1510-7. — View Citation

Li CI, Daling JR, Malone KE. Age-specific incidence rates of in situ breast carcinomas by histologic type, 1980 to 2001. Cancer Epidemiol Biomarkers Prev. 2005 Apr;14(4):1008-11. — View Citation

Love SM, Barsky SH. Anatomy of the nipple and breast ducts revisited. Cancer. 2004 Nov 1;101(9):1947-57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 to 4 weeks following the Day 15 intraductal infusion	Yes
Secondary	characterize i.d. carboplatin pharmacokinetics		4 -8 weeks	Yes
Secondary	characterize clinical extent of disease on MRI and/or mammogram		2 - 4 weeks	No
Secondary	characterize the histopathological assessment of DCIS		4 - 10 weeks	No
Secondary	Biomarker measurement of Ki-67, TUNEL and G-actin		4 - 8 weeks	No