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Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: September 5, 2008
Last updated: August 23, 2016
Last verified: August 2016
This phase II trial studies how well bevacizumab works in treating patients with sex cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.

Condition Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: September 2008
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Bevacizumab
Given IV
Other Names:
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Avastin
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients diagnosed with histologically confirmed recurrent ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma], steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules)
  • Patients must have measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria

    • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each "target" lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT
  • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
  • Patients of childbearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
  • Patients who have met the pre-entry requirements specified
  • There are no restrictions on prior therapy; however, patients cannot have previously had treatment with bevacizumab
  • Absolute neutrophil count (ANC) >= 1,000/µl
  • Platelets greater than or equal to 75,000/µl
  • Creatinine =< 1.5 x institutional upper limit normal (ULN)
  • Bilirubin =< 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) less 2.5 x ULN
  • Alkaline phosphatase less 2.5 x ULN
  • Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 grade 1
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.2 times the upper limit of normal
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

  • Patients with newly diagnosed disease
  • Patients with serious non-healing wound, ulcer, or bone fracture
  • Patients who have received prior therapy with bevacizumab or other inhibitors of vascular endothelial growth factor (VEGF)
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of the first date of treatment on this study
  • Patients with clinically significant cardiovascular disease; this includes:

    • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
    • Myocardial infarction or unstable angina within 6 months prior to registration
    • New York Heart Association (NYHA) grade II or greater congestive heart failure
    • Serious cardiac arrhythmic requiring medication.
    • Grade 2 or greater peripheral vascular disease
  • Patients with GOG performance grade of 3 or 4
  • Patients with clinically significant peripheral arterial disease; e.g., claudication within 6 months
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically; a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
  • Patients with a history of cardiovascular accident (CVA) within 6 months prior to registration
  • Patients with any signs of bowel obstruction or patients who require parenteral hydration and/or nutrition
  • Patients whose circumstances do not permit completion of the study or the required follow-up
  • Patients who are pregnant or nursing; patients who may become pregnant must agree to use contraceptive measures during the study and for at least 3 months after the completion of bevacizumab therapy
  • Patients who have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipate the need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
  • Patients with active infection requiring parenteral antibiotics
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00748657

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Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Jubilee Brown NRG Oncology
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00748657     History of Changes
Other Study ID Numbers: NCI-2009-00611  NCI-2009-00611  CDR0000613531  GOG-0251  GOG-0251  GOG-0251  U10CA180868  U10CA027469 
Study First Received: September 5, 2008
Results First Received: May 27, 2015
Last Updated: August 23, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sertoli-Leydig Cell Tumor
Sex Cord-Gonadal Stromal Tumors
Granulosa Cell Tumor
Leydig Cell Tumor
Ovarian Neoplasms
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Testicular Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Testicular Diseases
Antibodies, Monoclonal
Immunoglobulin G
Endothelial Growth Factors
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors processed this record on October 26, 2016