Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer

NCT00537173 | Terminated DMC

• 2 other identifiers: HOG COE-02DoD Grant BC030400
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 4

Brief Summary

This trial provides a unique opportunity in that it combines genomic, proteomic and pharmacogenomic assessments in patients receiving chemotherapy for advanced breast cancer. To date no other trials have 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, we expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, we expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To correlate tumor gene expression (genomic profile) with response to paclitaxel + Avastin in patients with advanced breast cancer

  36 months

Secondary Outcomes (1)

• To correlate serum and tumor proteomic profiles with response; To compare serum and tissue proteomic analyses; To compare genomic and proteomic profiles; To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.

  36 months

Study Arms (1)

Arm 1

Paclitaxel 90 mg/m2 IV D1, 8, and 15 + Avastin 10 mg/kg IV, day 1 and 15

Procedure: Core Biopsy; Procedure: Blood Collection; Drug: Paclitaxel; Drug: Avastin

Interventions

Core Biopsy PROCEDURE

biopsy

Arm 1

Blood Collection PROCEDURE

Blood/serum sample

Arm 1

Paclitaxel DRUG

Paclitaxel 90 mg/m2 IV, day 1, 8 and 15

Arm 1

Avastin DRUG

Avastin 10 mg/kg IV, day 1 and 15

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population is limited to patients with advanced breast cancer who are receiving paclitaxel + Avastin

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent, locally advanced (that is not amenable to resection with curative intent), or metastatic disease.
• Patients must consent to have a biopsy performed to obtain fresh tissue or be able to identify a FFPE tissue block in which tissue samples can be obtained to complete the testing for this study.
• Planned chemotherapy regimen of paclitaxel and Avastin for the treatment of metastatic breast cancer.
• Females age \> 18 years
• Written informed consent and HIPAA authorization for release of personal health information.

You may not qualify if:

• Patients must not have had chemotherapy for locally recurrent or metastatic breast cancer.
• Hormonal therapy for locally recurrent or metastatic disease must have been discontinued at least 2 weeks prior to study entry.
• Patients must not have had adjuvant or neoadjuvant taxane therapy within 12 months prior to study entry.
• Breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin.
• Patients must not have had a major surgical procedure within 4 weeks prior to study entry. (Placement of vascular access device, and breast biopsy, will not be considered major surgery.)
• Patients must not have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days of starting protocol therapy.
• Patients must not have had radiation within 2 weeks prior to study entry.
• Previously radiated area(s) must not be the only site of disease for study entry.
• Patients must not have a history of bleeding diathesis or have used anticoagulant therapy within 10 days of study entry. (Low dose anticoagulant therapy to maintain patency of a vascular access device is allowed.)
• Patients with a history of deep vein thrombosis or pulmonary embolism are not eligible.
• Aspirin usage (\> 325 mg/day) or other nonsteroidal anti-inflammatory medications known to inhibit platelet function daily are not allowed within 10 days prior to study entry.
• Patients currently using any of the following drugs known to inhibit platelet function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal).
• Patients must not have a history of TIA or CVA within 6 months prior to study entry.
• Patients must not have a history or radiologic evidence of CNS metastases including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement (head CT or MRI must be obtained within 6 weeks prior to study entry).
• Patients must not have a non-healing wound or fracture.

Sponsors & Collaborators

• Hoosier Cancer Research Network: lead
• United States Department of Defense: collaborator
• Indiana University School of Medicine: collaborator
• University of Colorado, Denver: collaborator
• Baylor University: collaborator
• McGill University: collaborator

Study Sites (4)

Cancer Care Center of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Baylor College of Medicine - Methodist Breast Center

Houston, Texas, 77030, United States

Location

Related Links

• Hoosier Oncology Group Home Page

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tumor samples

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Needle; Blood Specimen Collection; Paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• George Sledge, M.D.

  Hoosier Oncology Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 28, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

US (4)