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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403130
• Other study ID #: IRB-13761
• Secondary ID: 96052BRSMTS0007
• Status: Completed
• Phase: Phase 2
• Start date: February 2006
• Est. completion date: November 2012

Study information

• Verified date: January 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Gemcitabine
Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
• Paclitaxel
Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
• Bevacizumab
Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
George Albert Fisher	Eli Lilly and Company, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response Rates	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.	24 weeks
Secondary	Overall Survival (OS), Confirmed	Overall Survival (OS) as determined by confirmed date of death. Participants without documentation as either alive or deceased as of 6 years from the start of treatment were considered lost-to-follow-up.	6 years
Secondary	Overall Survival (OS), All Participants	Overall Survival (OS), based on date of death or last known date alive	6 years