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A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC 704865, IND 7921) for Recurrent Sex Cord-Stromal Tumors of the Ovary

Phase 2
18 Years
Open (Enrolling)
Ovarian Stromal Cancer

Thank you

Trial Information

A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC 704865, IND 7921) for Recurrent Sex Cord-Stromal Tumors of the Ovary


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


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.


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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Jubilee Brown

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

Related Keywords:

  • Ovarian Stromal Cancer
  • Ovarian Neoplasms
  • Sex Cord-Gonadal Stromal Tumors



Memorial Sloan Kettering Cancer Center New York, New York  10021
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Hartford Hospital Hartford, Connecticut  06102-5037
Carolinas Medical Center Charlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
MetroHealth Medical Center Cleveland, Ohio  44109
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Zale Lipshy University Hospital Dallas, Texas  75235-7786
Northwestern University Chicago, Illinois  60611
University of Massachusetts Medical School Worcester, Massachusetts  01605
Riverside Methodist Hospital Columbus, Ohio  43214
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
M D Anderson Cancer Center Houston, Texas  77030
University of Southern California Los Angeles, California  90033
The Hospital of Central Connecticut New Britain, Connecticut  06050
Cancer Care Associates-Yale Tulsa, Oklahoma  74136-1929
University of Minnesota Medical Center-Fairview Minneapolis, Minnesota  55455
Los Angeles County-USC Medical Center Los Angeles, California  90033
University of Massachusetts Memorial Health Care Worcester, Massachusetts  01605