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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00748657 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent sex cord-stromal tumors of the ovary.
Condition | Intervention | Phase |
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Ovarian Cancer |
Biological: bevacizumab Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC 704865, IND 7921) for Recurrent Sex Cord-Stromal Tumors of the Ovary |
Estimated Enrollment: | 37 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected at baseline and analyzed by immunohistochemistry to quantify expressions of angiogenic or lymphangiogenic biomarkers.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian stromal tumor, including any of the following:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Active bleeding or pathologic conditions that carry a high risk of bleeding, including any of the following:
History or evidence of other CNS disease by physical exam, including any of the following:
Clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Connecticut | |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | Recruiting |
New Britain, Connecticut, United States, 06050 | |
Contact: Clinical Trials Office - George Bray Cancer Center 860-224-5660 | |
Helen and Harry Gray Cancer Center at Hartford Hospital | Recruiting |
Hartford, Connecticut, United States, 06102-5037 | |
Contact: Clinical Trials Office - Helen and Harry Gray Cancer Center 860-545-5363 | |
United States, Illinois | |
Hinsdale Hematology Oncology Associates | Recruiting |
Hinsdale, Illinois, United States, 60521 | |
Contact: Sudarshan K. Sharma, MD 630-856-6757 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242-1002 | |
Contact: Cancer Information Service 800-237-1225 | |
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
United States, Mississippi | |
University of Mississippi Cancer Clinic | Recruiting |
Jackson, Mississippi, United States, 39216 | |
Contact: James T. Thigpen, MD 601-984-5590 | |
United States, North Carolina | |
Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
Charlotte, North Carolina, United States, 28232-2861 | |
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
Riverside Methodist Hospital Cancer Care | Recruiting |
Columbus, Ohio, United States, 43214-3998 | |
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
United States, Oklahoma | |
Cancer Care Associates - Saint Francis Campus | Recruiting |
Tulsa, Oklahoma, United States, 74136-1929 | |
Contact: Robert S. Mannel, MD 405-271-8787 | |
Oklahoma University Cancer Institute | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Robert S. Mannel, MD 405-271-8787 | |
United States, Pennsylvania | |
Rosenfeld Cancer Center at Abington Memorial Hospital | Recruiting |
Abington, Pennsylvania, United States, 19001 | |
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M 215-481-2402 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Study Chair: | Jubilee Brown, MD | M.D. Anderson Cancer Center |
Investigator: | David M. Gershenson, MD | M.D. Anderson Cancer Center |
Responsible Party: | Gynecologic Oncology Group ( Philip J. DiSaia ) |
Study ID Numbers: | CDR0000613531, GOG-0251 |
Study First Received: | September 5, 2008 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00748657 History of Changes |
Health Authority: | Unspecified |
ovarian stromal cancer |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Bevacizumab |
Angiogenesis Inhibitors Recurrence Genital Diseases, Female Sex Cord-Gonadal Stromal Tumors Ovarian Cancer Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms by Histologic Type Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Growth Substances Physiological Effects of Drugs Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Bevacizumab Ovarian Diseases Angiogenesis Inhibitors |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Sex Cord-Gonadal Stromal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Gonadal Tissue Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms |