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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00748657 |
Purpose
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 |
|---|---|---|
|
Ovarian Cancer |
Biological: bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.
Eligibility| 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:
Contacts and Locations
Show 31 Study Locations| Study Chair: | Jubilee Brown, MD | M.D. Anderson Cancer Center |
| Investigator: | David M. Gershenson, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00748657 History of Changes |
| Other Study ID Numbers: | CDR0000613531, GOG-0251 |
| Study First Received: | September 5, 2008 |
| Last Updated: | February 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian stromal cancer |
|
Ovarian Neoplasms Sex Cord-Gonadal Stromal Tumors Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Neoplasms, Gonadal Tissue Neoplasms by Histologic Type Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |