Status:
COMPLETED
Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Female Reproductive Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 grow...
Detailed Description
PRIMARY OBJECTIVES: 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 stabilizati...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed soft tissue sarcoma of gynecologic tract including 1 of the following subtypes: uterine leiomyosarcoma, malignant mixed mullerian tumor/carcinosarcoma, disease originating in ovary/fallopian tube allowed
- Locally advanced/unresectable/metastatic disease
- Previously treated disease must have radiographic/clinical evidence of PD
- Measurable disease-at least 1 lesion in at least 1 dimension (longest diameter) as \>=20mm with conventional techniques or as \>=10mm with spiral CT scan
- Indicator lesions may not have been previously treated with surgery/radiotherapy/radiofrequency ablation unless PD has been confirmed
- ECOG PS 0-2 OR Karnofsky PS 60-100%
- Life expectancy\>=3 months
- WBC\>=3,000/mm\^3
- Absolute neutrophil count\>=1,500/mm\^3
- Platelet count\>=75,000/mm\^3
- Bilirubin=\<1.5xULN
- AST and ALT=\<3xULN
- INR=\<1.5 (unless on warfarin)
- Creatinine=\<1.5xULN OR creatinine clearance\>=60 mL/min
- Urine protein\<1+ by dipstick OR 24-hour urine protein\<500 mg OR urine protein:creatinine ratio\<1
- Not pregnant/nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥6 months after treatment - No other active malignancy within past 5 years except adequately treated cervical carcinoma in situ/nonmelanoma skin cancer
- No known hypersensitivity to Chinese hamster ovary cell products/other recombinant human antibodies
- No history of allergic reactions attributed to compounds of similar chemical/biological composition to study agents
- No serious/nonhealing wound/ulcer/bone fracture
- No abdominal fistula/gastrointestinal perforation/bowel obstruction/intraabdominal abscess within past 28 days
- No significant traumatic injuries within past 28 days
- No evidence of bleeding diathesis/coagulopathy
- No uncontrolled intercurrent illness including but not limited to: Ongoing/active infection, psychiatric illness or social situations that would preclude study compliance
- \<=2 prior cytotoxic chemotherapy regimen for recurrent, locally advanced or metastatic disease
- Recovered from prior therapy
- No prior antiangiogenic agent
Exclusion
- \< 4weeks since prior chemotherapy (\<6 weeks for nitrosoureas/carmustine/mitomycin C), prior investigational treatment, radiotherapy and major surgery/open biopsy
- 1 week since prior core biopsy
- 1 month since prior thrombolytic agents
- Concurrent full-dose anticoagulants with INR\>1.5 allowed if: In-range INR (usually between 2-3) on stable dose of oral anticoagulant or low molecular weight heparin,
- OR; For patients on warfarin, the upper target for INR is ≤3 No active bleeding/pathological condition that carries a high risk of bleeding (e.g. tumor invading major vessels/known varices)
- No evidence of CNS disease including primary brain tumor/brain metastasis
- No other concurrent investigational agents - No concurrent major surgery
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Clinically significant cardiovascular disease including:
- Cerebrovascular accident within past 6 months,
- Uncontrolled hypertension defined as BP\>150/100mmHg OR systolic BP\>180mmHg if diastolic BP\<90 mmHg, on ≥2 repeated determinations on separate days within past 3 months,
- OR; Antihypertensive medications allowed as long as dose and number of antihypertensive medications have not increased within past 2 weeks, Myocardial infarction, coronary artery bypass graft, or unstable angina within past 6 months, OR;
- OR; NYHA class III-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris within past 6 months, Clinically significant peripheral vascular disease within past 6 months
- OR; pulmonary embolism, deep vein thrombosis, or other thromboembolic event within past 6 months
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00390234
Start Date
September 1 2006
End Date
August 1 2013
Last Update
December 7 2015
Active Locations (16)
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1
City of Hope
Duarte, California, United States, 91010
2
University of Southern California
Los Angeles, California, United States, 90033-0804
3
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
4
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470