Combination Gemcitabine, Carboplatin With or Without Tras... | NCT00193076

Studies
Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

NCT00193076

Sponsor

SCRI Development Innovations, LLC

Status

Completed

Last Update Posted

May 3, 2011Estimated

Enrollment

96Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Gemcitabine
Carboplatin
Trastuzumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

May 2006Actual

Completion Date

Oct 2008Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2011

Last Update Posted Date

May 3, 2011Estimated

Name	Class
Eli Lilly and Company	INDUSTRY
Genentech, Inc.	INDUSTRY

Description Module

Brief Summary

Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.

Detailed Description

Upon determination of eligibility, all patients will receive the following treatment:

Gemcitabine + Carboplatin

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Name	Type	Description
Gemcitabine	Drug	Gemcitabine
Carboplatin	Drug	Carboplatin
Trastuzumab	Drug	Trastuzumab

Measure	Description	Time Frame
Overall response rates		18 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Locally advanced or metastatic breast cancer
Measurable disease as per RECIST criteria
No prior chemotherapy in the metastatic breast setting
Prior chemotherapy and/or hormonal therapy for early stage breast cancer
Adjuvant Herceptin is allowed
Prior radiation therapy in either the metastatic or early stage setting
Patients may have received any number of hormonal therapies
Age >18 years
Only women are eligible for the study
Able to perform activities of daily living with minimal assistance
Normal organ and bone marrow function
Patients who will be receiving Trastuzumab must have normal heart function
Sign a written informed consent document

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Received prior chemotherapy for metastatic breast cancer
Known leptomeningeal carcinomatosis
Uncontrolled brain metastasis
Uncontrolled intercurrent illness
Pregnant or lactating
History of other non-breast cancer malignancy
Received prior chemotherapy for early stage breast cancer within 6 months

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Denise A. Yardley, MD	SCRI Development Innovations, LLC	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Tennessee Oncology		Nashville	Tennessee	37203	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18952556	Result	Yardley DA, Burris HA 3rd, Simons L, Spigel DR, Greco FA, Barton JH, Shipley D, Drosick D, Hainsworth JD. A phase II trial of gemcitabine/carboplatin with or without trastuzumab in the first-line treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2008 Oct;8(5):425-31. doi: 10.3816/CBC.2008.n.051.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

ID	Term
D000093542	Gemcitabine
D016190	Carboplatin
D000068878	Trastuzumab

ID	Type	Description	Link
B9E-US-S324
H3036S