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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00390234 |
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 |
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 |
Estimated Enrollment: | 82 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed soft tissue sarcoma of the gynecologic tract, including 1 of the following subtypes:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
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
No uncontrolled intercurrent illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
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
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 |
Study Chair: | Amit M. Oza, MD | Princess Margaret Hospital, Canada |
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 |
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 |
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 |
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 |