Trial | NCT00669747  Report issue

Title

Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    carboplatin sodium chloride ...

  • Study Participants

    45
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.
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.
Study Started
May 31
2008
Primary Completion
Sep 30
2009
Anticipated
Study Completion
Dec 31
2009
Anticipated
Last Update
Oct 02
2008
Estimate

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 names: Paraplatin

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 names: Paraplatin

Drug Normal Saline

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

A Experimental

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

B Experimental

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

C Placebo Comparator

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

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
No Results Posted