Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
Part of paid clinical trials in Duarte, California.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00390234
- Phase
- PHASE2
- Status
- Completed
Conditions
- 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
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ziv-aflibercept — DRUGGiven IV
Study Details
This phase II trial is studying how well ziv-aflibercept works in treating patients with locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma. Ziv-aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Key Dates
- Start date
- Sep 30, 2006
- Status verified
- May 2013
- Primary completion
- Sep 30, 2011
- Completion
- Aug 31, 2013
Study Design
- Enrollment
- 63 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- 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.
Primary Outcome Measure
Objective Response Rate, Evaluated According to the RECIST Criteria [ Time Frame: Up to 3 years ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | - |
| University of Southern California | Los Angeles | California | 90033-0804 | - |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | - |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637-1470 | - |
| Evanston CCOP-NorthShore University HealthSystem | Evanston | Illinois | 60201 | - |
| Peoria Gynecologic Oncology | Peoria | Illinois | 61603 | - |
| University of Michigan University Hospital | Ann Arbor | Michigan | 48109 | - |
| Fox Chase Cancer Center | Rockledge | Pennsylvania | 19046 | - |
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