Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. To estimate the anti-tumor activity of bevacizumab by assessing the frequency of objective response in patients with recurrent sex cord-stromal tumors of the ovary.

Secondary

1. To determine the nature and degree of toxicity of this drug in these patients.
2. To determine the overall survival of these patients.
3. To determine the progression-free survival of these patients.

Tertiary

1. To quantify expression of angiogenic or lymphangiogenic markers in recurrent stromal tumors of the ovary to determine frequency of alterations and potential utility of biologic agents directed at these proteins for inclusion in future studies.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

• 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

Patient Characteristics:

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Expected Enrollment

Outcomes

Tumor response rate (complete and partial response)

Overall survival
Progression-free survival
Expression of angiogenic or lymphangiogenic markers (i.e., VEGF ligand, receptor, and activated receptor; EGF ligand, receptor, and activated receptor; β-catenin; LYVE-1 [lymphatic marker]; IL-8; ER-alpha; ER-beta; and androgen receptor)

Outline

This is a multicenter study.

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.

After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Jubilee Brown, MD, Protocol chair		Ph: 713-792-1380; 800-392-1611
David Gershenson, MD, Protocol co-chair		Ph: 713-745-2565; 800-392-1611

Registry Information
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
Trial Start Date		2008-09-22
Trial Completion Date		2011-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00748657
Date Submitted to PDQ		2008-08-27
Information Last Verified		2011-01-29
NCI Grant/Contract Number		CA27469

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