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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00623233
Other study ID # 11649
Secondary ID B9E-US-S379
Status Completed
Phase Phase 2
First received February 13, 2008
Last updated December 2, 2011
Start date March 2008
Est. completion date January 2011

Study information

Verified date December 2011
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be female and greater than or equal to 18 yrs of age

- Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.

- Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy

- Participants may have received prior hormone therapy for locally recurrent or metastatic disease

Exclusion Criteria:

- Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification

- Prior chemotherapy or targeted therapy for metastatic breast cancer

- Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting

- History of, or active brain mets

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study

- Prior history of high blood pressure crisis

- Have a serious, nonhealing wound, ulcer, or bone fracture

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Gemcitabine
Gemcitabine 2500 mg/m^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.
Bevacizumab
Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event [AE], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.) Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.

Locations

Country Name City State
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Augusta Georgia
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbia South Carolina
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fairfield Connecticut
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fayetteville Arkansas
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fresno California
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Germantown Tennessee
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Great Falls Montana
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lambertville Michigan
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Longmont Colorado
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashville Tennessee
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Newport News Virginia
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oklahoma City Oklahoma
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salt Lake City Utah
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Diego California
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) Time PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date. Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months). No
Secondary Overall Tumor Response Rate (ORR) Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: complete response (CR)=disappearance of all target lesions; partial response (PR)=30% decrease in sum of longest diameter of target lesions; progressive disease (PD)=20% increase in sum of longest diameter of target lesions; stable disease=small changes that do not meet above criteria. ORR=proportion of participants who achieved a confirmed best response of CR or PR (responders). ORR=number of participants with CR or PR /number of participants qualified for tumor response analysis (per protocol population). Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months). No
Secondary Number of Participants With Adverse Events (AEs); Pharmacology Toxicities A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module. Baseline, every cycle (every 14 days) up to 34 months Yes
Secondary 1-Year Overall Survival (OS) Rate OS was measured from the date of first dose to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date for a particular analysis, OS duration was censored for that analysis at the date of participant's last study contact prior to that cut-off date. The 1-year survival rate (percentage of participants who were alive at 1 year) was estimated from OS data. Baseline to death from any cause, 1 year No
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