NCT00390234

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 21, 2014

Completed
Last Updated

December 7, 2015

Status Verified

May 1, 2013

Enrollment Period

5 years

First QC Date

October 18, 2006

Results QC Date

November 14, 2014

Last Update Submit

December 3, 2015

Conditions

Fallopian Tube CancerFemale Reproductive CancerOvarian CarcinosarcomaOvarian SarcomaRecurrent Ovarian Epithelial CancerRecurrent Uterine SarcomaStage III Ovarian Epithelial CancerStage III Uterine SarcomaStage IV Ovarian Epithelial CancerStage IV Uterine SarcomaUterine CarcinosarcomaUterine Leiomyosarcoma

Outcome Measures

Primary Outcomes (3)

  • Objective Response Rate, Evaluated According to the RECIST Criteria

    Up to 3 years

  • Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)

    6 months

  • Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)

    6 months

Secondary Outcomes (2)

  • Survival (Leiomyosarcoma Group)

    Up to 3 years

  • Survival (Carcinosarcoma Group)

    Up to 3 years

Study Arms (1)

Treatment (ziv-aflibercept)

EXPERIMENTAL

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.

Drug: ziv-aflibercept

Interventions

ziv-afliberceptDRUG

Given IV

Also known as: aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap
Treatment (ziv-aflibercept)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +13 more criteria

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
  • week since prior core biopsy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

City of Hope

Duarte, California, 91010, United States

Location

University of Southern California

Los Angeles, California, 90033-0804, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

Evanston CCOP-NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Peoria Gynecologic Oncology

Peoria, Illinois, 61603, United States

Location

University of Michigan University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Fox Chase Cancer Center

Rockledge, Pennsylvania, 19046, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5C 1M9, Canada

Location

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal Disorders

Results Point of Contact

Title
Dr. Amit Oza
Organization
Princess Margaret Hospital
amit.oza@uhn.ca
416-946-2818

Study Officials

  • Amit Oza

    University Health Network-Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2011

Study Completion

August 1, 2013

Last Updated

December 7, 2015

Results First Posted

November 21, 2014

Record last verified: 2013-05

Locations

CA(8)US(8)