Ductal Carcinoma In SituPhase 2NCT00669747
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
A Phase 2 study testing Carboplatin i.d. Days 1 & 15, Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 and Normal Saline in people with Ductal Carcinoma In Situ, run by Windy Hill Medical, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Carcinoma In Situ
- What is being tested?
- Carboplatin i.d. Days 1 & 15, Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Henry Kuerer, M.D., 713-745-5043, lboehnke@mdanderson.org
Linda White, R.N., 949 300-9576, lwhite@whmed.com
- Recruiting
OU Medical Center Laboratory
Oklahoma City, Oklahoma, 73104
William C Dooley, M.D., F.A.C.S., 405-206-5670, William-Dooley@ouhsc.edu
Linda White, R.N., (949) 300-9576, lwhite@whmed.com
About this study
Official title: A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
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.
Read the 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.
- Conditions
- Ductal Carcinoma In Situ
- Being tested
- Carboplatin i.d. Days 1 & 15, Carboplatin i.d. Day 1; Normal Saline i.d. Day 15, Normal Saline
- Keywords
- Ductal Carcinoma In Situ, DCIS, Breast Cancer, Carboplatin, Intraductal
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin i.d. Days 1 & 15Drug
Also called Paraplatin
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 15Drug
Also called Paraplatin
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 SalineDrug
Normal Saline, 10 ml, i.d. on Days 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Carboplatin infused into DCIS-involved duct on Days 1 \& 15 Receives: Drug: Carboplatin i.d. Days 1 & 15 |
| B | Experimental | Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15 Receives: Drug: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 |
| C | Placebo comparator | Normal Saline infused into DCIS-involved duct Days 1 \& 15 Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 to 4 weeks following the Day 15 intraductal infusion
Secondary outcomes (4)
characterize i.d. carboplatin pharmacokinetics
Measured: 4 -8 weeks
characterize clinical extent of disease on MRI and/or mammogram
Measured: 2 - 4 weeks
characterize the histopathological assessment of DCIS
Measured: 4 - 10 weeks
Biomarker measurement of Ki-67, TUNEL and G-actin
Measured: 4 - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ductal Carcinoma In SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Windy Hill Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jane Doerr, RN, MSN, Study director, Windy Hill Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669747
- Sponsor's protocol ID
- DCIS-WHM-703M
- Status last verified
- Oct 2008
- First submitted
- 28 Apr 2008
- Last updated
- 2 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15382093Li 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.
PubMed 15824180Khan 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.
PubMed 15494601
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
- ClinicalTrials.gov ID
- NCT00669747
- Acronym / sponsor ID
- DCIS-WHM-703M
- Conditions
- Ductal Carcinoma In Situ
- Keywords
- Ductal Carcinoma In Situ, DCIS, Breast Cancer, Carboplatin, Intraductal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Windy Hill Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Carboplatin i.d. Days 1 & 15Carboplatin infused into DCIS-involved duct on Days 1 \& 15 |
| B | Experimental | Drug: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15 |
| C | Placebo comparator | Drug: Normal SalineNormal Saline infused into DCIS-involved duct Days 1 \& 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carboplatin i.d. Days 1 & 15Also: ParaplatinCarboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 \& 15 | Drug | A |
| Carboplatin i.d. Day 1; Normal Saline i.d. Day 15Also: ParaplatinCarboplatin 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 | Drug | B |
| Normal SalineNormal Saline, 10 ml, i.d. on Days 1 and 15 | Drug | C |
Primary outcome
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
4 secondary outcomes
characterize i.d. carboplatin pharmacokinetics
Time frame: 4 -8 weeks
characterize clinical extent of disease on MRI and/or mammogram
Time frame: 2 - 4 weeks
characterize the histopathological assessment of DCIS
Time frame: 4 - 10 weeks
Biomarker measurement of Ki-67, TUNEL and G-actin
Time frame: 4 - 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2008.
- Background: PubMed 15382093Love SM, Barsky SH. Anatomy of the nipple and breast ducts revisited. Cancer. 2004 Nov 1;101(9):1947-57. doi: 10.1002/cncr.20559.
- Background: PubMed 15824180Li 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.
- Background: PubMed 15494601Khan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Doerr, RN, MSN study director
Windy Hill Medical, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin i.d. Days 1 & 15, Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 and Normal Saline in people with Ductal Carcinoma In Situ, run by Windy Hill Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Doerr, RN, MSN (949-636-4737, jdoerr@whmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00669747, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2008.