Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
Genentech
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00623233
First received: February 13, 2008
Last updated: December 2, 2011
Last verified: December 2011
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Purpose
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer Locally Advanced Breast Cancer |
Drug: Gemcitabine Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of Gemcitabine and Bevacizumab as First-Line Treatment in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Previously Treated With Taxanes |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Progression Free Survival (PFS) Time [ Time Frame: 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). ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Overall Tumor Response Rate (ORR) [ Time Frame: 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). ] [ Designated as safety issue: No ]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).
- Number of Participants With Adverse Events (AEs); Pharmacology Toxicities [ Time Frame: Baseline, every cycle (every 14 days) up to 34 months ] [ Designated as safety issue: Yes ]A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.
- 1-Year Overall Survival (OS) Rate [ Time Frame: Baseline to death from any cause, 1 year ] [ Designated as safety issue: No ]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.
| Enrollment: | 52 |
| Study Start Date: | March 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gemcitabine + Bevacizumab
Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity. Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity. |
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.
Other Names:
Drug: 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623233
Locations
| United States, Arkansas | |
| 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, 72703 | |
| United States, California | |
| 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, 93720 | |
| 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, 92121 | |
| United States, Colorado | |
| 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, 80501 | |
| United States, Connecticut | |
| 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, 06824 | |
| United States, Georgia | |
| 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, 30901 | |
| United States, Michigan | |
| 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, 48144 | |
| United States, Missouri | |
| 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, United States, 63141 | |
| United States, Montana | |
| 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, 59405 | |
| United States, New York | |
| 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, 10003 | |
| United States, Oklahoma | |
| 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, 73112 | |
| United States, South Carolina | |
| 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, 29210 | |
| United States, Tennessee | |
| 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, 38138 | |
| 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, 37203 | |
| United States, Utah | |
| 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, 84106 | |
| United States, Virginia | |
| 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, 23601 | |
Sponsors and Collaborators
Eli Lilly and Company
Genentech
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00623233 History of Changes |
| Other Study ID Numbers: | 11649, B9E-US-S379 |
| Study First Received: | February 13, 2008 |
| Results First Received: | December 2, 2011 |
| Last Updated: | December 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
Breast Neoplasm |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Bevacizumab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents |
Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013