Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
|ClinicalTrials.gov Identifier: NCT00390234|
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : November 21, 2014
Last Update Posted : December 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Female Reproductive Cancer Ovarian Carcinosarcoma Ovarian Sarcoma Recurrent Ovarian Epithelial Cancer Recurrent Uterine Sarcoma Stage III Ovarian Epithelial Cancer Stage III Uterine Sarcoma Stage IV Ovarian Epithelial Cancer Stage IV Uterine Sarcoma Uterine Carcinosarcoma Uterine Leiomyosarcoma||Drug: ziv-aflibercept||Phase 2|
I. To assess the objective response of recurrent or metastatic gynecologic soft-tissue sarcomas to VEGF-Trap (ziv-aflibercept).
II. To assess the incidence of disease stabilization, as measured by 6-month progression-free survival, in patients with recurrent or metastatic gynecologic soft-tissue sarcomas treated with VEGF-Trap.
I. To assess time-to-progression and overall survival in patients with recurrent or metastatic gynecologic soft-tissue sarcoma treated with VEGF-Trap.
* As of 24 October 2012, overall survival follow-up is to be discontinued for the one remaining patient on long term follow-up, who has been off protocol therapy for at least 3 years. Time to progression and median survival times have been based on the currently available data.
II. To assess the toxicity associated with VEGF-Trap in patients with recurrent or metastatic gynecologic soft-tissue sarcoma.
III. To characterize the population pharmacokinetics of VEGF-Trap and to explore for demographic and clinical covariates
OUTLINE: This is an open-label, multicenter study.
Patients are stratified according to histology (uterine leiomyosarcoma vs malignant mixed mullerian tumor/carcinosarcoma). Patients receive ziv-aflibercept over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline, every 8 weeks during treatment, and 60 days after completion of study treatment for population pharmacokinetic analysis using enzyme-linked immunosorbent assay (ELISA).
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas|
|Study Start Date :||September 2006|
|Primary Completion Date :||September 2011|
|Study Completion Date :||August 2013|
Experimental: Treatment (ziv-aflibercept)
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
- Objective Response Rate, Evaluated According to the RECIST Criteria [ Time Frame: Up to 3 years ]
- Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group) [ Time Frame: 6 months ]
- Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group) [ Time Frame: 6 months ]
- Survival (Leiomyosarcoma Group) [ Time Frame: Up to 3 years ]Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.
- Survival (Carcinosarcoma Group) [ Time Frame: Up to 3 years ]Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390234
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|University of Southern California|
|Los Angeles, California, United States, 90033-0804|
|UC Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Evanston CCOP-NorthShore University HealthSystem|
|Evanston, Illinois, United States, 60201|
|Peoria Gynecologic Oncology|
|Peoria, Illinois, United States, 61603|
|United States, Michigan|
|University of Michigan University Hospital|
|Ann Arbor, Michigan, United States, 48109|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Rockledge, Pennsylvania, United States, 19046|
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5C 1M9|
|BCCA-Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Odette Cancer Centre- Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|McGill University Department of Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|Principal Investigator:||Amit Oza||University Health Network-Princess Margaret Hospital|