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

Brief Title

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

Official Title

A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC# 704865) for Recurrent Sex Cord-Stromal Tumors of the Ovary

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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      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.

      SECONDARY OBJECTIVES:

      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.

      TERTIARY OBJECTIVES:

      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.

      OUTLINE:

      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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Tumor Response

Secondary Outcome

 Progression-free Survival

Condition

Malignant Ovarian Epithelial Tumor

Intervention

Bevacizumab

Study Arms / Comparison Groups

 Treatment (bevacizumab)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

36

Start Date

September 22, 2008

Completion Date

January 31, 2013

Primary Completion Date

January 31, 2013

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jubilee Brown, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00748657

Organization ID

NCI-2009-00611

Secondary IDs

NCI-2009-00611

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 NRG Oncology

Study Sponsor

Jubilee Brown, Principal Investigator, NRG Oncology


Verification Date

July 2019