Phase 2 N=63 Treatment

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

Fallopian Tube Cancer · Female Reproductive Cancer · Ovarian Carcinosarcoma · Ovarian Sarcoma · Recurrent Ovarian Epithelial Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00390234 ↗

Enrolled (actual)

Serious AEs

46.0%

Results posted

Nov 2014

Primary outcome: Primary: Objective Response Rate, Evaluated According to the RECIST Criteria — 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ziv-aflibercept (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: National Cancer Institute (NCI)
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate, Evaluated According to the RECIST Criteria	—	—
PRIMARY Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)	0.17	—
PRIMARY Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)	1.6	—
SECONDARY Survival (Leiomyosarcoma Group)	18.1	—
SECONDARY Survival (Carcinosarcoma Group)	3.2	—

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 growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Eligibility Criteria

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= =60 mL/min
Urine protein 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00390234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.