Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
Recruitment status was Recruiting
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ |
- 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 ]
- 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 ]
| 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
Other Name: Normal Saline
|
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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00669747
| Contact: Jane Doerr, RN, MSN | 949-636-4737 | jdoerr@whmed.com | |
| Contact: Andy Dorr, MD | 949-584-4975 | andy.dorr@whmed.com |
| 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 | |
| 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 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Windy Hill Medical, Inc.:
|
Ductal Carcinoma In Situ DCIS Breast Cancer Carboplatin Intraductal |
Additional relevant MeSH terms:
|
Carcinoma, Ductal, Breast Carcinoma in Situ Carcinoma, Ductal Carcinoma, Intraductal, Noninfiltrating Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Neoplasms |
Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Carboplatin Antineoplastic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015