Clinical trial NCT00403130: Phase 2 Study of Gemzar, Taxol & Avastin Combination as 1st Line Treatment for Metastatic Breast Cancer
Official title: Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Eli Lilly and Company
First posted: 2006-11-23
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.

Detailed description: This study will evaluate the time-to-progression (TTP) in patients with metastatic breast cancer, receiving 1st line therapy with bevacizumab in combination with paclitaxel and gemcitabine.

Secondary objectives will include response rates and overall survival (OS).

Eligibility criteria: INCLUSION CRITERIA

* Previously-untreated metastatic breast cancer. 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.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Granulocyte count ≥ 1500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL.
* Serum glutamic oxaloacetic transaminase (SGOT) / serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x the institutional upper limit of normal (ULN) if alkaline phosphatase is ≤ ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are ≤ ULN.
* Total bilirubin within institutional limits of normal.
* Calculated creatinine clearance ≥ 30 mL/min using the formula: Ccr(mL/min) = \[(140-age in years) X (wt in kg) X 0.85 (females)\]/(72 x serum creatinine in mg/dL)
* ≥ 18 years of age.
* Prior anthracycline treatment 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 pre-treatment multigated acquisition (MUGA) scan or echocardiogram (ECHO).
* All patients must give signed written informed consent.
* May have received adjuvant therapy as long as therapy complete \> 12 months from study entry.
* Females of childbearing potential must have a negative pregnancy test taken ≤ 2 weeks prior to study enrollment, and must consent to the use of effective contraception during the study period and for 6months thereafter.

EXCLUSION CRITERIA

* Receiving hormonal therapy
* Prior treatment for metastatic disease with cytotoxic agents or inhibitors of epidermal growth factor receptor (EGFR)
* Her2NEU-positive breast cancers, by either immunohistochemistry (IHC) score 3+ or fluorescence in situ hybridization (FISH)
* Pregnant or lactating.
* 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.
* Active or unresolved infection.
* Pre-existing peripheral neuropathy \> Grade 1.
* Prior history of severe hypersensitivity reaction to paclitaxel, gemcitabine, bevacizumab or drugs formulated with polysorbate 80.
* 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

Primary outcomes:
measure: Time-to-Progression (TTP)
timeFrame: 2 years
Secondary outcomes:
measure: Response Rates
timeFrame: 24 weeks
measure: Overall Survival (OS), Confirmed
timeFrame: 6 years
measure: Overall Survival (OS), All Participants
timeFrame: 6 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: George A Fisher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guardino A, et al. "Phase II Trial with Gemcitabine, Paclitaxel and Bevacizumab for the First Line Treatment of Metastatic Breast Cancer." Cancer Res. 2009;69(24_suppl)abs6089.