Phase 2 Study of Gemzar, Taxol & Avastin Combination as 1st Line Treatment for Metastatic Breast Cancer

NCT ID: NCT00403130

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2012-11-30

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).

Conditions

Breast Cancer; Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase II 3-drug regimen

Gemcitabine + Paclitaxel + Bevacizumab

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles

Paclitaxel

Intervention Type: DRUG

Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles

Bevacizumab

Intervention Type: DRUG

Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles

Interventions

Gemcitabine

Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles

Intervention Type: DRUG

Paclitaxel

Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles

Intervention Type: DRUG

Bevacizumab

Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles

Intervention Type: DRUG

Other Intervention Names

Gemzar; Taxol; Avastin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

George Albert Fisher

OTHER

Sponsor Role: lead

Responsible Party

George Albert Fisher

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

George A Fisher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

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.

Reference Type: RESULT

Other Identifiers

96052

Identifier Type: OTHER

Identifier Source: secondary_id

BRSMTS0007

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-13761

Identifier Type: -

Identifier Source: org_study_id