A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer - Full Text View

Sponsors and Collaborators:	Hoosier Oncology Group Department of Defense Indiana University School of Medicine Walther Cancer Institute
Information provided by:	Hoosier Oncology Group
ClinicalTrials.gov Identifier:	NCT00235235

Purpose

The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.

Condition	Intervention
Breast Cancer	Procedure: Biopsy Procedure: Serum Collection Procedure: Urine Collection Drug: Doxorubicin Drug: Cyclophosphamide Drug: Capecitabine Drug: Vinorelbine Drug: Gemcitabine

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Urine and Urination

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01

Further study details as provided by Hoosier Oncology Group:

Primary Outcome Measures:

To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To compare serum and tissue proteomic analyses. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To compare genomic and proteomic profiles. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To correlate toxicity and/or response with drug-specific pharmacogenomic parameters. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle	Procedure: Biopsy core biopsy Procedure: Serum Collection serum collection Procedure: Urine Collection urine collection Drug: Doxorubicin Doxorubicin 60 mg/m2 day 1 of every 21-day cycle Drug: Cyclophosphamide Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
B: Active Comparator Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle	Procedure: Biopsy core biopsy Procedure: Serum Collection serum collection Procedure: Urine Collection urine collection Drug: Capecitabine Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
C: Active Comparator Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle	Procedure: Biopsy core biopsy Procedure: Serum Collection serum collection Procedure: Urine Collection urine collection Drug: Vinorelbine Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
D: Active Comparator Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle	Procedure: Biopsy core biopsy Procedure: Serum Collection serum collection Procedure: Urine Collection urine collection Drug: Gemcitabine Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

Detailed Description:

OUTLINE: This is a 4 arm, multi-center study.

Sample Collection:

Core Biopsy
Serum
Urine

Treatment Regimens (Investigator/Patient Discretion):

Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
Arm B: Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
Arm C: Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
Arm D: Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

Performance status & Organ Function:

Performance status and organ function appropriate for chemotherapy in the opinion of the treating investigator according to Good Clinical Practice (GCP).

Life Expectancy: Not specified

Hematopoietic: Not specified

Hepatic: Not specified

Renal: Not specified

Cardiovascular: Not specified

Pulmonary: Not specified

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis.
Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST.
Planned chemotherapy with one of the following regimens:
1. Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
2. Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
3. Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
4. Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

Exclusion Criteria:

No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation.
Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential.
Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy.
No breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235235

Contacts

Contact: Kathy Miller, M.D.	317-274-0920	kathmill@iupui.edu
Contact: Jayme Harvey	317-921-2050	harveyj@iupui.edu

Locations

United States, Indiana
Indiana University Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kathy Miller, M.D. 317-274-0920 kathmill@iupui.edu
Contact: Kerry Bridges 317-274-2552 kdbridge@iupui.edu
Mary Lou Mayer, M.D.	Terminated
Indianapolis, Indiana, United States, 46227
Cancer Care Center of Southern Indiana	Recruiting
Bloomington, Indiana, United States, 47403
Contact: Karuna Koneru, M.D. 812-323-1535
Contact: Kim Hahn, R.N. 812-353-2828 khahn@bloomhealth.org
Center for Cancer Care at Goshen Health System	Recruiting
Goshen, Indiana, United States, 46527
Contact: Daniel Bruetman, M.D. 574-535-2886
Contact: Helen Orvis, R.N. 574-535-2893 horvis@goshenhealth.com
Community Regional Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Sumeet Bhatia, M.D. 317-621-7104
Contact: Lisa McVicker, R.N. 317-621-7104
Horizon Oncology Center	Recruiting
Lafayette, Indiana, United States, 47905
Contact: Wael Harb, M.D. 765-446-5111 wharb@thecaregroup.com
Contact: Linda Vaders, R.N. 765.446.5111 lvaders@thecaregroup.com
Northern Indiana Cancer Research Consortium	Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon, M.D. 574-234-5123
Contact: Susan Haithcox, R.N. 574-647-7977 shaithcox@memorialsb.org
Peru
Instituto de Enfermedades Neoplasticas (INEN)	Recruiting
Lima, Peru
Contact: Henry Gomez, M.D.
Contact: Denisse Morales +51 1 710-6900 ext 2261

Sponsors and Collaborators

Hoosier Oncology Group

Department of Defense

Indiana University School of Medicine

Walther Cancer Institute

Investigators

Study Chair:	Kathy Miller, M.D.	Hoosier Oncology Group, LLC
Principal Investigator:	George Sledge, M.D.	Hoosier Oncology Group, LLC

More Information

Hoosier Oncology Group Home Page This link exits the ClinicalTrials.gov site

Responsible Party:	Hoosier Oncology Group ( Kathy Miller, M.D. )
Study ID Numbers:	HOG COE-01, Department of Defense BC030400
Study First Received:	October 6, 2005
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00235235
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Capecitabine
Vinorelbine
Skin Diseases
Breast Neoplasms

Cyclophosphamide
Gemcitabine
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009