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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Windy Hill Medical, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Windy Hill Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00669747
First received: April 28, 2008
Last updated: October 1, 2008
Last verified: October 2008

April 28, 2008
October 1, 2008
May 2008
September 2009   (final data collection date for primary 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 [ Time Frame: 2 to 4 weeks following the Day 15 intraductal infusion ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00669747 on ClinicalTrials.gov Archive Site
  • characterize i.d. carboplatin pharmacokinetics [ Time Frame: 4 -8 weeks ] [ Designated as safety issue: Yes ]
  • characterize clinical extent of disease on MRI and/or mammogram [ Time Frame: 2 - 4 weeks ] [ Designated as safety issue: No ]
  • characterize the histopathological assessment of DCIS [ Time Frame: 4 - 10 weeks ] [ Designated as safety issue: No ]
  • Biomarker measurement of Ki-67, TUNEL and G-actin [ Time Frame: 4 - 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ductal Carcinoma In Situ
  • Drug: Carboplatin i.d. Days 1 & 15
    Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 & 15
    Other Name: Paraplatin
  • Drug: 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
    Other Name: Paraplatin
  • Drug: Normal Saline
    Normal Saline, 10 ml, i.d. on Days 1 and 15
    Other Name: Normal Saline
  • Experimental: A
    Carboplatin infused into DCIS-involved duct on Days 1 & 15
    Intervention: Drug: Carboplatin i.d. Days 1 & 15
  • Experimental: B
    Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15
    Intervention: Drug: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15
  • Placebo Comparator: C
    Normal Saline infused into DCIS-involved duct Days 1 & 15
    Intervention: Drug: Normal Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Jane Doerr, RN, MSN 949-636-4737 jdoerr@whmed.com
Contact: Andy Dorr, MD 949-584-4975 andy.dorr@whmed.com
United States
 
NCT00669747
DCIS-WHM-703M
No
Windy Hill Medical, Inc. (Ms. Jane Doerr, R.N., Director of Clinical Development), Windy Hill Medical, Inc.
Windy Hill Medical, Inc.
Not Provided
Study Director: Jane Doerr, RN, MSN Windy Hill Medical, Inc.
Windy Hill Medical, Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP