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Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study


OUTLINE: This is a multi-center study.

Sample Collection:

- Core biopsy

- Blood sample

28-day Cycle Treatment Regimen:

- Paclitaxel 90 mg/m2 IV D1, 8, and 15

- Avastin 10 mg/kg IV D1 and 15

ECOG Performance Status of 0 or 1

Life Expectancy: Not specified

Hematopoietic:

- Platelet count > 100,000/mm³

- Absolute neutrophil count > 1200/mm³

- PTT < 1.5 x upper limit of normal

- INR < 1.5 x upper limit of normal

Hepatic:

- Total bilirubin < 1.5 mg/dL

- SGOT (AST) < 2 x upper limit of normal

Renal: Not specified

Cardiovascular:

- Clinically significant cardiovascular or cerebrovascular disease including prior
myocardial infarction (within 6 months prior to study entry), unstable angina, Grade II
or greater peripheral vascular disease, New York Heart Association (NYHA) Grade II or
greater congestive heart failure, hypertensive crises, hypertensive encephalopathy or
uncontrolled hypertension (SBP>150, DBP>100).


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

- Patients must not have a hypersensitivity to paclitaxel or drugs using the vehicle
Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies.

- Females must not be pregnant or breastfeeding. Females of childbearing potential must
use an accepted and effective method of contraception (hormonal or barrier method of
birth control; abstinence) while on treatment and for a 3 month period thereafter.

- Females of childbearing potential must have a negative pregnancy test within 7 days
prior to being registered for protocol therapy. Subjects are considered not of
child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
postmenopausal.

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study entry

- Urine protein: creatinine (UPC) ratio > 1.0 at baseline or urine protein dipstick >
2+.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

George Sledge, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hoosier Oncology Group, Inc.

Authority:

United States: Institutional Review Board

Study ID:

HOG COE-02

NCT ID:

NCT00537173

Start Date:

September 2007

Completion Date:

August 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Horizon Oncology CenterLafayette, Indiana  47905
Baylor College of Medicine - Methodist Breast CenterHouston, Texas  77030
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202