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

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ClinicalTrials.gov Identifier: NCT00669747
Recruitment Status : Unknown
Verified October 2008 by Windy Hill Medical, Inc..
Recruitment status was:  Recruiting
First Posted : April 30, 2008
Last Update Posted : October 2, 2008
Sponsor:
Information provided by:
Windy Hill Medical, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ductal Carcinoma In Situ Drug: Carboplatin i.d. Days 1 & 15 Drug: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 Drug: Normal Saline Phase 2

Detailed 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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
Study Start Date : May 2008
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Carboplatin infused into DCIS-involved duct on Days 1 & 15
 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
Experimental: B
Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15
 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
Placebo Comparator: C
Normal Saline infused into DCIS-involved duct Days 1 & 15
 Drug: Normal Saline
Normal Saline, 10 ml, i.d. on Days 1 and 15


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. characterize i.d. carboplatin pharmacokinetics [ Time Frame: 4 -8 weeks ]
  2. characterize clinical extent of disease on MRI and/or mammogram [ Time Frame: 2 - 4 weeks ]
  3. characterize the histopathological assessment of DCIS [ Time Frame: 4 - 10 weeks ]
  4. Biomarker measurement of Ki-67, TUNEL and G-actin [ Time Frame: 4 - 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669747


Contacts
Contact: Jane Doerr, RN, MSN 949-636-4737 jdoerr@whmed.com
Contact: Andy Dorr, MD 949-584-4975 andy.dorr@whmed.com

Locations
United States, Oklahoma
OU Medical Center Laboratory Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: William C Dooley, M.D., F.A.C.S.    405-206-5670    William-Dooley@ouhsc.edu   
Contact: Linda White, R.N.    (949) 300-9576    lwhite@whmed.com   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Henry Kuerer, M.D.    713-745-5043    lboehnke@mdanderson.org   
Contact: Linda White, R.N.    949 300-9576    lwhite@whmed.com   
Sponsors and Collaborators
Windy Hill Medical, Inc.
Investigators
Study Director: Jane Doerr, RN, MSN Windy Hill Medical, Inc.
More Information
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Publications:

Responsible Party: Windy Hill Medical, Inc. (Ms. Jane Doerr, R.N., Director of Clinical Development), Windy Hill Medical, Inc.
ClinicalTrials.gov Identifier: NCT00669747     History of Changes
Other Study ID Numbers: DCIS-WHM-703M
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: October 2, 2008
Last Verified: October 2008

Keywords provided by Windy Hill Medical, Inc.:
Ductal Carcinoma In Situ
DCIS
Breast Cancer
Carboplatin
Intraductal

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ
Carboplatin
Antineoplastic Agents