Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed · Phase 2

Conditions studied: Recurrent Endometrial Carcinoma

In brief

This phase II trial is studying how well bevacizumab works in treating patients with recurrent or persistent endometrial cancer. 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.

Key facts

Study ID

NCT00301964

Run by

National Cancer Institute (NCI)

People needed

56

Starts

2006-03-01

Expected to finish

2011-07-01

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Recurrent or persistent endometrial carcinoma with histologic confirmation of the original primary tumor
• Refractory to curative therapy or established treatments
• Measurable disease
• At least one non previously irradiated lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Previously irradiated lesion allowed provided disease progression is documented or a biopsy obtained to confirm persistent disease ≥ 90 days after completion of prior radiotherapy
• Must have received 1 prior chemotherapy regimen for endometrial carcinoma
• May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
• Not eligible for a higher priority GOG protocol, if one exists
• No tumor involving major vessels
• No prior history or evidence of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases
• GOG performance status (PS) 0-2 (if received 1 prior treatment regimen)
• GOG PS 0-1 (if received 2 prior treatment regimens)
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Serum bilirubin ≤ 1.5 times ULN
• SGOT and alkaline phosphatase ≤ 2.5 times ULN
• Urine protein:creatinine ratio < 1.0
• INR < 1.5 (or in-range, usually between 2 and 3, if the patient is on a stable dose of therapeutic warfarin)
• PTT < 1.5 times ULN
• No active infection requiring antibiotics
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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