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

Completed · Phase 2

Conditions studied: 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

In brief

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 facts

Study ID: NCT00390234
Run by: National Cancer Institute (NCI)
People needed: 63
Starts: 2006-09-01
Expected to finish: 2013-08-01
Last updated by the study team: 2015-12-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

< 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

Where it is running

City of Hope — Duarte, California, United States
University of Southern California — Los Angeles, California, United States
UC Davis Comprehensive Cancer Center — Sacramento, California, United States
University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Evanston CCOP-NorthShore University HealthSystem — Evanston, Illinois, United States
Peoria Gynecologic Oncology — Peoria, Illinois, United States
University of Michigan University Hospital — Ann Arbor, Michigan, United States
Fox Chase Cancer Center — Rockledge, Pennsylvania, United States
Vancouver General Hospital — Vancouver, British Columbia, Canada
BCCA-Vancouver Cancer Centre — Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital — Kingston, Ontario, Canada
London Regional Cancer Program — London, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
University Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada
McGill University Department of Oncology — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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