Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
Recruitment status was Recruiting
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First Received Date ICMJE | April 28, 2008 | ||||||||
Last Updated Date | October 1, 2008 | ||||||||
Start Date ICMJE | May 2008 | ||||||||
Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00669747 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS) | ||||||||
Official Title ICMJE | A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ | ||||||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Ductal Carcinoma In Situ | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 45 | ||||||||
Estimated Completion Date | December 2009 | ||||||||
Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion 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:
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Gender | Female | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00669747 | ||||||||
Other Study ID Numbers ICMJE | DCIS-WHM-703M | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Windy Hill Medical, Inc. (Ms. Jane Doerr, R.N., Director of Clinical Development), Windy Hill Medical, Inc. | ||||||||
Study Sponsor ICMJE | Windy Hill Medical, Inc. | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Windy Hill Medical, Inc. | ||||||||
Verification Date | October 2008 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |