This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier:
NCT00403130
First received: November 22, 2006
Last updated: February 3, 2017
Last verified: February 2017
  Purpose
Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.

Condition Intervention Phase
Breast Cancer Metastatic Breast Cancer Drug: Gemcitabine Drug: Paclitaxel Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by George Albert Fisher, Stanford University:

Primary Outcome Measures:
  • Time-to-Progression (TTP) [ Time Frame: 2 years ]
    Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans.


Secondary Outcome Measures:
  • Response Rates [ Time Frame: 24 weeks ]

    The best overall response was recorded for each participant from randomization until disease progression/recurrence, using any increase from the smallest measurements recorded since randomization as the indicator of Progressive Disease (PD).

    Overall response was determined on the basis of response at the target and non-target lesions, and the appearance of new lesions, as follows.

    Target Nontarget New Lesions Overall Response

    • Complete Complete None Overall Complete Response
    • Complete Incomplete response/ None Overall Partial Response Stable Disease (SD)
    • Partial Not PD None Overall Partial Response
    • SD Not PD None Overall Stable Disease
    • PD Any Yes/No Overall PD
    • Any PD Yes/No Overall PD
    • Any Any Yes Overall PD

    Overall Response Rate (ORR) was assessed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate.


  • Overall Survival (OS), Confirmed [ Time Frame: 6 years ]
    Overall Survival (OS) as determined by confirmed date of death

  • Overall Survival (OS), All Participants [ Time Frame: 6 years ]
    Overall Survival (OS), based on date of death or last known date alive


Enrollment: 31
Study Start Date: February 2006
Study Completion Date: November 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase II 3-drug regimen
Gemcitabine + Paclitaxel + Bevacizumab
Drug: Gemcitabine
Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
Other Name: Gemzar
Drug: Paclitaxel
Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
Other Name: Taxol
Drug: Bevacizumab
Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
Other Name: Avastin

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403130

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
George Albert Fisher
Genentech, Inc.
Eli Lilly and Company
Investigators
Principal Investigator: George A Fisher, MD, PhD Stanford University
  More Information

Publications:
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.

Responsible Party: George Albert Fisher, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00403130     History of Changes
Other Study ID Numbers: IRB-13761
96052 ( Other Identifier: Stanford University alternate IRB Number )
BRSMTS0007 ( Other Identifier: OnCore study number )
Study First Received: November 22, 2006
Results First Received: February 3, 2017
Last Updated: February 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on June 22, 2017