Clinical trial NCT00669747: Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
Official title: A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ductal Carcinoma In Situ
Keywords: Ductal Carcinoma In Situ
DCIS
Breast Cancer
Carboplatin
Intraductal
Lead sponsor: Windy Hill Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-30
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
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
timeFrame: 2 to 4 weeks following the Day 15 intraductal infusion
Secondary outcomes:
measure: characterize i.d. carboplatin pharmacokinetics
timeFrame: 4 -8 weeks
measure: characterize clinical extent of disease on MRI and/or mammogram
timeFrame: 2 - 4 weeks
measure: characterize the histopathological assessment of DCIS
timeFrame: 4 - 10 weeks
measure: Biomarker measurement of Ki-67, TUNEL and G-actin
timeFrame: 4 - 8 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Medical Center Laboratory
state: Oklahoma
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Windy Hill Medical, Inc.
name: Jane Doerr, RN, MSN
role: STUDY_DIRECTOR
References:
citation: Love SM, Barsky SH. Anatomy of the nipple and breast ducts revisited. Cancer. 2004 Nov 1;101(9):1947-57. doi: 10.1002/cncr.20559.
citation: Li CI, Daling JR, Malone KE. Age-specific incidence rates of in situ breast carcinomas by histologic type, 1980 to 2001. Cancer Epidemiol Biomarkers Prev. 2005 Apr;14(4):1008-11. doi: 10.1158/1055-9965.EPI-04-0849.
citation: Khan SA, Wiley EL, Rodriguez N, Baird C, Ramakrishnan R, Nayar R, Bryk M, Bethke KB, Staradub VL, Wolfman J, Rademaker A, Ljung BM, Morrow M. Ductal lavage findings in women with known breast cancer undergoing mastectomy. J Natl Cancer Inst. 2004 Oct 20;96(20):1510-7. doi: 10.1093/jnci/djh283.