Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Windy Hill Medical, Inc..
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Windy Hill Medical, Inc.
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
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ |
Resource links provided by NLM:
Further study details as provided by Windy Hill Medical, Inc.:
Primary Outcome Measures:
- 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:
- characterize i.d. carboplatin pharmacokinetics [ Time Frame: 4 -8 weeks ]
- characterize clinical extent of disease on MRI and/or mammogram [ Time Frame: 2 - 4 weeks ]
- characterize the histopathological assessment of DCIS [ Time Frame: 4 - 10 weeks ]
- Biomarker measurement of Ki-67, TUNEL and G-actin [ Time Frame: 4 - 8 weeks ]
| Estimated Enrollment: | 45 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669747
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 |
| Study First Received: | April 28, 2008 |
| Last Updated: | October 1, 2008 |
Keywords provided by Windy Hill Medical, Inc.:
|
Ductal Carcinoma In Situ DCIS Breast Cancer Carboplatin Intraductal |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Ductal Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Carboplatin Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 25, 2017