A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer
The purpose of this study is to look at a new chemotherapy schedule in metastatic breast cancer.
Metastatic Breast Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Biweekly Gemcitabine, Paclitaxel, and Avastin as Frontline Therapy for Metastatic Breast Cancer|
- To assess the progression-free survival in patients receiving biweekly Paclitaxel + Gemcitabine + Avastin as first-line therapy for metastatic breast cancer. [ Time Frame: 11/2010 ] [ Designated as safety issue: No ]
- To estimate the overall response rate (OPR-complete and partial) in the subset of patients with measurable disease, overall survival (OS) at 3 years and to assess the toxicity of the combination therapy. [ Time Frame: 11/2012 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment Period
Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
Other Name: PaclitaxelDrug: Gemcitabine
Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
Other Name: GemcitabineDrug: Avastin
10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
Other Name: Avastin
The purpose of this study is to determine whether a new chemotherapy schedule using biweekly combination of paclitaxel (Taxol®), gemcitabine (Gemzar®) and Avastin would help to lessen in-between-cycle growth of resistant cells and to evaluate the toxicity of this therapy.
Taxol is approved by the Food and Drug Administration (FDA) for use in metastatic breast and metastatic ovarian cancer but its use in this study is investigational. Gemzar is FDA approved for the use in breast, lung and pancreatic cancer but its use in this study is investigational.
The Avastin being given in this study is commercially available, however, it has not been approved by FDA for use in metastatic breast cancer.
|United States, Ohio|
|University of Cincinnati Dept. of Medicine, Div. Hem/Onc|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Kathleen Havlin, MD||University of Cincinnati|