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Trial record 3 of 79 for:    FKB238

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00748657
Recruitment Status : Completed
First Posted : September 8, 2008
Results First Posted : June 10, 2015
Last Update Posted : July 23, 2019
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 22, 2008
Actual Primary Completion Date : January 31, 2013
Actual Study Completion Date : January 31, 2013

Arm Intervention/treatment
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
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar FKB238
  • 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ]
    Adverse Events at least possibly related to study agent.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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/?l
  • Platelets greater than or equal to 75,000/?l
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00748657

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Sponsors and Collaborators
National Cancer Institute (NCI)
NRG Oncology
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Principal Investigator: Jubilee Brown NRG Oncology
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00748657    
Other Study ID Numbers: NCI-2009-00611
NCI-2009-00611 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0251 ( Other Identifier: NRG Oncology )
GOG-0251 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2008    Key Record Dates
Results First Posted: June 10, 2015
Last Update Posted: July 23, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Sex Cord-Gonadal Stromal Tumors
Leydig Cell Tumor
Granulosa Cell Tumor
Sertoli-Leydig Cell Tumor
Ovarian Neoplasms
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Antineoplastic Agents, Immunological
Endothelial Growth Factors
Antibodies, Monoclonal
Immunoglobulin G
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances