Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma

Inclusion Criteria

• •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