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

NCT00403130 | Completed Phase 2 Results DMC

• 3 other identifiers: IRB-1376196052BRSMTS0007
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time-to-Progression (TTP)

  Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)

  2 years

Secondary Outcomes (3)

• Response Rates

  24 weeks

• Overall Survival (OS), Confirmed

  6 years

• Overall Survival (OS), All Participants

  6 years

Study Arms (1)

Phase II 3-drug regimen

EXPERIMENTAL

Gemcitabine + Paclitaxel + Bevacizumab

Drug: Gemcitabine; Drug: Paclitaxel; Drug: Bevacizumab

Interventions

Gemcitabine DRUG

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

Also known as: Gemzar

Phase II 3-drug regimen

Paclitaxel DRUG

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

Also known as: Taxol

Phase II 3-drug regimen

Bevacizumab DRUG

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

Also known as: Avastin

Phase II 3-drug regimen

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• George Albert Fisher: lead
• Genentech, Inc.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; 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

Results Point of Contact

• Title: George Albert Fisher, MD, PhD
• Organization: Stanford University Medical Center

georgeaf@stanford.edu

650-725-9057

Study Officials

• George A Fisher, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 22, 2006
• First Posted: November 23, 2006
• Study Start: February 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2012
• Last Updated: February 20, 2019
• Results First Posted: March 24, 2017

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)