The purpose of this study is to evaluate the effectiveness of the combination of Avastin and Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian cancer within 12 months of platinum chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States
Women's Cancer Associates
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Duke Cancer Institute
Durham, North Carolina, United States
Six Month Progression Free Survival (PFS)
Percentage of participants with PFS at six months. PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.
Time frame: 6 months per participant
Median Progression Free Survival
PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.
Time frame: Up to 5 years
Overall Response Rate (RR)
Overall Response: Complete Response (CR) + Partial Response (PR). To determine the response rate (RR) of the investigational treatment regimen. Response and progression were evaluated in the study by using the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) method or modified Rustin Criteria for CA-125 measurements.
Time frame: Up to 5 years
Occurrence of Grade 3 or 4 Toxicity
Number of participants with Grade 3 or 4 Toxicity based on 278 treatment cycles. Toxicity was graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: Up to 4 years
Overall Survival (OS)
Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) were analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.
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Time frame: Up to 5 years