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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00748657
First received: September 5, 2008
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

This phase II trial is studying how well bevacizumab works in treating patients with recurrent sex cord-stromal tumors of the ovary. 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.


Condition Intervention Phase
Ovarian Stromal Cancer
Biological: bevacizumab
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, IND 7921) 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 rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From entry into the study to death or the date of last contact, up to 5 years ] [ Designated as safety issue: No ]
    Overall survival will be estimated and graphed using the Kaplan-Meier product-limit method.

  • Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact, up to 5 years ] [ Designated as safety issue: No ]
    Progression free survival will be estimated and graphed using the Kaplan-Meier product-limit method.

  • 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: 35
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 humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

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 of this drug 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: This is a multicenter study.

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 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
Criteria

Inclusion Criteria:

  • Histologically confirmed ovarian stromal tumor, including any of the following:

    • 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
  • Recurrent disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No tumor involving major vessels
  • No history or evidence of primary brain tumor or brain metastases by physical exam
  • GOG performance status 0-2
  • ANC ≥ 1,000/µL
  • Platelet count ≥ 75,000/µL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT < 2.5 times ULN
  • Alkaline phosphatase < 2.5 times ULN
  • INR ≤ 1.5 (in-range INR [2-3] if patient is on a stable dose of therapeutic warfarin)
  • PTT < 1.2 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • Serious non-healing wound, ulcer, or bone fracture
  • Active bleeding or pathologic conditions that carry a high risk of bleeding, including any of the following:

    • Known bleeding disorder
    • Coagulopathy
  • History or evidence of other CNS disease by physical exam, including any of the following:

    • Seizures not controlled with standard medical therapy
    • Cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
  • Sensory and motor neuropathy > grade 1 (according to NCI CTCAE v3.0)
  • Clinically significant cardiovascular disease, including any of the following:

    • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg
    • Myocardial infarction or unstable angina within the past 6 months
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmic requiring medication
    • Peripheral vascular disease ≥ grade 2
  • Clinically significant peripheral artery disease (e.g., claudication within the past 6 months)
  • Clinically significant proteinuria (urine protein:creatinine ratio ≥ 1.0)
  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Bowel obstruction or requirement for parenteral hydration and/or nutrition
  • Significant traumatic injury within the past 28 days
  • Active infection requiring parenteral antibiotics
  • Other invasive malignancies within the past 5 years, except non-melanoma skin cancer
  • No prior treatment with bevacizumab or other VEGF inhibitors
  • No prior cancer treatment that contraindicates study therapy
  • No major surgical procedure or open biopsy within the past 28 days
  • No vascular access device placement or core biopsy within the past 7 days
  • No concurrent major surgery
  • No other concurrent chemotherapy, radiotherapy, immunotherapy, or hormonal therapy directed against the tumor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748657

  Show 24 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Jubilee Brown Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00748657     History of Changes
Other Study ID Numbers: NCI-2009-00611, NCI-2009-00611, CDR0000613531, GOG-0251, GOG-0251, GOG-0251, U10CA027469
Study First Received: September 5, 2008
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sex Cord-Gonadal Stromal Tumors
Ovarian Neoplasms
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antibodies
Antibodies, Monoclonal
Bevacizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014