Recruiting
Phase 2

Carboplatin

Sponsor:

Windy Hill Medical, Inc.

Code:

NCT00669747

Conditions

Ductal Carcinoma In Situ

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carboplatin i.d. Days 1 & 15

Carboplatin i.d. Day 1; Normal Saline i.d. Day 15

Normal Saline

Study Details

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.

Conditions

Ductal Carcinoma In Situ

Study ID

NCT00669747

Start date

May, 2008

Status verified date

Oct, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Sep, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

Carboplatin infused into DCIS-involved duct on Days 1 \& 15

experimental: B

Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15

placebo comparator: C

Normal Saline infused into DCIS-involved duct Days 1 \& 15

Interventions

Carboplatin i.d. Days 1 & 15

Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 \& 15

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

Normal Saline

Normal Saline, 10 ml, i.d. on Days 1 and 15

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 ]

Central Contacts and Locations

Central contacts

Jane Doerr, RN, MSN

949-636-4737jdoerr@whmed.com

Andy Dorr, MD

949-584-4975andy.dorr@whmed.com

Locations

OU Medical Center Laboratory

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

William C Dooley, M.D., F.A.C.S.

405-206-5670William-Dooley@ouhsc.edu

Linda White, R.N.

(949) 300-9576lwhite@whmed.com

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Henry Kuerer, M.D.

713-745-5043lboehnke@mdanderson.org

Linda White, R.N.

949 300-9576lwhite@whmed.com

More Information

Sponsor

Windy Hill Medical, Inc.

Last update posted

Oct 2, 2008

Last verified

Oct, 2008

Keywords

  • Ductal Carcinoma In Situ
  • DCIS
  • Breast Cancer
  • Carboplatin
  • Intraductal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Windy Hill Medical, Inc. on 2008-10-02.