Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary
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|ClinicalTrials.gov Identifier: NCT00748657|
Recruitment Status : Completed
First Posted : September 8, 2008
Results First Posted : June 10, 2015
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Ovarian Epithelial Tumor Ovarian Granulosa Cell Tumor Ovarian Gynandroblastoma Ovarian Sertoli-Leydig Cell Tumor Ovarian Sex Cord Tumor With Annular Tubules Ovarian Sex Cord-Stromal Tumor Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types Ovarian Steroid Cell Tumor||Biological: Bevacizumab Other: Laboratory Biomarker Analysis||Phase 2|
I. To estimate the anti-tumor activity of bevacizumab by assessing frequency of objective response in patients with recurrent sex cord-stromal tumors of the ovary who have measurable disease.
I. To determine the nature and degree of toxicity in these patients. II. To determine the overall survival and progression-free survival of these patients.
I. To quantify expression of angiogenic or lymphangiogenic markers in recurrent stromal tumors of the ovary to determine the frequency of alterations and potential utility of biologic agents directed at these proteins for inclusion in future studies.
Patients receive bevacizumab intravenously (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 treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary|
|Actual Study Start Date :||September 22, 2008|
|Actual Primary Completion Date :||January 31, 2013|
|Actual Study Completion Date :||January 31, 2013|
Experimental: Treatment (bevacizumab)
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.
Other: Laboratory Biomarker Analysis
- Tumor Response [ Time Frame: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels ]Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
- Progression-free Survival [ Time Frame: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels ]Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
- Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years. ]The observed length of life from entry into the study to death or the date of last contact.
- Frequency and Severity of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748657
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|Principal Investigator:||Jubilee Brown||NRG Oncology|