A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
This study has been terminated.
(Funding terminated)
Sponsor:
Hoosier Oncology Group
Collaborators:
Indiana University School of Medicine
Walther Cancer Institute
Information provided by:
Hoosier Oncology Group
ClinicalTrials.gov Identifier:
NCT00235235
First received: October 6, 2005
Last updated: April 28, 2011
Last verified: April 2011
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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 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Doxorubicin
Doxorubicin hydrochloride
Vinorelbine
Gemcitabine
Gemcitabine hydrochloride
Vinorelbine tartrate
Capecitabine
U.S. FDA Resources
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 ]
Biospecimen Retention: Samples With DNA
core biopsy, serum, urine
| Enrollment: | 80 |
| Study Start Date: | September 2005 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
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
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
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
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 |
| Sampling Method: | Probability Sample |
Study Population
Study limited to patients with breast cancer.
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:
- Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
- Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
- Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
- 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
Locations
| United States, Indiana | |
| Cancer Care Center of Southern Indiana | |
| Bloomington, Indiana, United States, 47403 | |
| Fort Wayne Oncology & Hematology, Inc | |
| Fort Wayne, Indiana, United States, 46815 | |
| Center for Cancer Care at Goshen Health System | |
| Goshen, Indiana, United States, 46527 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Community Regional Cancer Center | |
| Indianapolis, Indiana, United States, 46256 | |
| Mary Lou Mayer, M.D. | |
| Indianapolis, Indiana, United States, 46227 | |
| Horizon Oncology Center | |
| Lafayette, Indiana, United States, 47905 | |
| Arnett Cancer Care | |
| Lafayette, Indiana, United States, 47904 | |
| Northern Indiana Cancer Research Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Texas | |
| Baylor College of Medicine - Methodist Breast Center | |
| Houston, Texas, United States, 77030 | |
| Peru | |
| Instituto de Enfermedades Neoplasticas (INEN) | |
| Lima, Peru | |
Sponsors and Collaborators
Hoosier Oncology Group
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
Additional Information:
No publications provided
| Responsible Party: | Kathy Miller, M.D., Hoosier Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00235235 History of Changes |
| Other Study ID Numbers: | HOG COE-01, Department of Defense BC030400 |
| Study First Received: | October 6, 2005 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Gemcitabine Vinorelbine Capecitabine Doxorubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013