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VEGF Trap in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
First Received: October 18, 2006   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00390234
  Purpose

RATIONALE: VEGF Trap 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.

PURPOSE: This phase II trial is studying how well VEGF Trap works in treating patients with locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Sarcoma
Biological: aflibercept
Other: immunoenzyme technique
Other: pharmacological study
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer Soft Tissue Sarcoma
Drug Information available for: Aflibercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Incidence of disease stabilization, as measured by progression-free survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Response as assessed by RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: September 2006
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with locally advanced, unresectable, or metastatic gynecologic soft tissue sarcomas treated with VEGF Trap.
  • Determine the incidence of disease stabilization, as measured by 6-month progression-free survival, in these patients.

Secondary

  • Determine time to progression and overall survival of these patients.
  • Determine the toxicity of this regimen in these patients.
  • Characterize the population pharmacokinetics and explore demographic and clinical covariates in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to histology (uterine leiomyosarcoma vs malignant mixed mullerian tumor/carcinosarcoma).

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline, every 8 weeks during treatment, and 60 days after completion of study treatment for population pharmacokinetic analysis using enzyme-linked immunosorbent assay (ELISA).

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed soft tissue sarcoma of the gynecologic tract, including 1 of the following subtypes:

    • Uterine leiomyosarcoma
    • Malignant mixed mullerian tumor/carcinosarcoma
    • Disease originating in the ovary or fallopian tube allowed
  • Locally advanced, unresectable, or metastatic disease
  • Previously treated disease must have radiographic or clinical evidence of progressive disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • Indicator lesions may not have been previously treated with surgery, radiotherapy, or radiofrequency ablation unless progressive disease has been confirmed
  • No evidence of CNS disease, including primary brain tumor or brain metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • INR ≤ 1.5 (unless on warfarin)
  • Creatinine ≤ 1.5 times ULN 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 or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • No other active malignancy within the past 5 years except adequately treated cervical carcinoma in situ or nonmelanoma skin cancer
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to study agents
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injuries within the past 28 days
  • No clinically significant cardiovascular disease, including any of the following:

    • Cerebrovascular accident within the past 6 months
    • Uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg OR systolic BP > 180 mm Hg if diastolic BP < 90 mm Hg, on ≥ 2 repeated determinations on separate days within the past 3 months

      • Antihypertensive medications allowed, as long as the dose and number of antihypertensive medications have not been increased within the past 2 weeks
    • Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
    • New York Heart Association class III-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris within the past 6 months
    • Clinically significant peripheral vascular disease within the past 6 months (i.e., limiting activities of daily living or the presence of pain at rest)
    • Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
  • No evidence of bleeding diathesis or coagulopathy
  • No uncontrolled intercurrent illness including, but not limited to, the following:

    • Ongoing or active infection
    • Psychiatric illness or social situations that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • No more than 2 prior cytotoxic chemotherapy regimen for recurrent, locally advanced, or metastatic disease
  • Recovered from prior therapy
  • No prior antiangiogenic agent
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin C)
  • At least 4 weeks since prior investigational treatment
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior major surgery or open biopsy
  • At least 1 week since prior core biopsy
  • At least 1 month since prior thrombolytic agents
  • Concurrent full-dose anticoagulants (e.g., warfarin) with INR > 1.5 allowed provided all the following criteria are met:

    • In-range INR (usually between 2-3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin

      • For patients on warfarin, the upper target for INR is ≤ 3
    • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor invading major vessels or known varices)
  • No other concurrent investigational agents
  • No concurrent major surgery
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390234

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente     323-865-0451        
Women's and Children's Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Huyen Pham, MD     323-226-3397        
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care     217-876-6601        
Evanston Northwestern Healthcare - Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev     847-570-1381        
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615-7828
Contact: Sachdev P. Thomas, MD     309-243-1000     sthomas@ohaci.com    
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive     800-865-1125        
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi     215-728-4790        
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers     412-647-8073        
Canada, Alberta
Cross Cancer Institute at University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Quincy Chu, MD     780-432-8248        
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Paul J. Hoskins, MD     604-877-6000 ext. 2365        
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: James Biagi, MD     613-544-2630 ext. 4502        
Edmond Odette Cancer Centre at Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Allan Covens, MD     416-480-4026     al.covens@sunnybrook.ca    
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Stephen Welch, MD     519-685-8500 ext. 54006        
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Hal W. Hirte, MD, FRCP(C)     905-387-9495 ext. 6460     Hal.Hirte@jcc.hhsc.ca    
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Amit M. Oza, MD     416-946-2818        
Canada, Quebec
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H3G 1Y6
Contact: Susie K.S. Lau, MD     514-398-1444        
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
  More Information

Additional Information:
No publications provided

Responsible Party: Princess Margaret Hospital ( Amit M. Oza )
Study ID Numbers: CDR0000508798, PMH-PHL-051, NCI-7502
Study First Received: October 18, 2006
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00390234     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ovarian carcinosarcoma
ovarian sarcoma
uterine carcinosarcoma
uterine leiomyosarcoma
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
recurrent uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
fallopian tube cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Ovarian Neoplasms
Leiomyosarcoma
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Uterine Sarcoma
Sarcoma
Ovarian Cancer
Endocrinopathy
Ovarian Carcinosarcoma
Carcinosarcoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Site
Sarcoma
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009