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Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer, Metastatic Breast Cancer

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Trial Information

Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer

This study will evaluate the efficacy by estimation of time to progression of Bevacizumab in
combination with Paclitaxel and Gemcitabine, as concurrent use of these two agents alone,
was shown to increase overall survival, time to progression, and response rate in previously
untreated metastatic breast cancer. The improvement in overall survival was based on an
interim analysis. It is hypothesized that this three-drug regimen will result in increased
time to progression and possibly higher response rates in the current study population.
Moreover, it is believed that this regimen will be well tolerated with minimal overlapping

Inclusion Criteria:

- Patients must have previously untreated metastatic breast cancer.

- Patients may have had prior chest wall irradiation or palliative radiation to bony
sites for control of pain or fracture. These sites of disease, however, will not be
considered as sites of measurable disease.

- Use of bisphosphonates will be permitted.

- Patients must have an ECoG performance status of 0 or 1.

- Patients must have adequate hepatic, renal and bone marrow function as defined by the

- granulocyte count >= 1500/mm^3

- platelet count >= 100,000/mm^3

- hemoglobin >=8.0 g/dl.

- SGoT/SGPT <= 2.5X the institutional upper limit of normal (ULN) if alkaline
phosphatase is d ULN or alkaline phosphatase may be up to 4X ULN if
transaminases are d ULN.

- total bilirubin within institutional limits of normal.

- calculated creatinine clearance >= 30 ml/min using the formula: a. Ccr(ml/min) =
((140-age in years) X (wt in kg) X 0.85 (females))/(72 X Serum creatinine in

- All patients must be >= 18 years of age.

- Patients with prior anthracyclines in the adjuvant setting or prior chest wall
radiation must have left ventricular ejection fraction (LVEF) within the
institutional range of normal as assessed by pretreatment MUGA scan or ECHo.

- All patients must give signed written informed consent. o Patients may have received
adjuvant therapy as long as therapy complete >12 months from study entry.

Exclusion Criteria:- Patients on hormonal therapy

- Patients had prior treatment for metastatic disease with cytotoxic agents or
inhibitors of EGFR.

- Her2NEU positive breast cancers, either IHC 3+ or FISH +.

- Patients who are pregnant/lactating. Patients of childbearing potential must have a
negative pregnancy test taken <= 2 weeks prior to study enrollment. Patients of
childbearing potential must consent to the use of effective contraception during the
study period and for six months thereafter.

- Patients have had active malignancies other than breast cancer in the past 5 years
with the exception of in situ carcinoma of the cervix or nonmelanomatous skin cancer.

- Patients have active or unresolved infection.

- Patients with pre-existing peripheral neuropathy > Grade 1.

- Patients with a prior history of severe hypersensitivity reaction to paclitaxel,
gemcitabine, bevacizumab or drugs formulated with polysorbate 80.

- Patients ineligible due to Bevacizumab-specific concerns:

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study.

- Blood pressure of >150/100 mmHg

- Unstable angina

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- History of myocardial infarction within 6 months

- History of stroke within 6 months

- Clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Presence of central nervous system or brain metastases

- Major surgical procedure, open biopsy, or significant traumatic injury within 28
days prior to Day 0, anticipation of need for major surgical procedure during
the course of the study

- Minor surgical procedures, fine needle aspirations or core biopsies within 7
days prior to Day 0

- Urine protein:creatinine ratio >= 1.0 at screening

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to comply with study and/or follow-up procedures

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression will be the primary outcome measure for this trial.

Outcome Time Frame:

At point of disease progression

Safety Issue:


Principal Investigator

George Albert Fisher M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

February 2006

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Breast Neoplasms



Stanford University School of MedicineStanford, California  94305-5317