Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT ID: NCT00301964

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-07-31

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Assess the activity of bevacizumab, in terms of 6-month progression-free survival rate and objective tumor response, in patients with recurrent or persistent endometrial cancer.

II. Determine the nature and degree of toxicity of bevacizumab in these patients.

SECONDARY OBJECTIVES:

I. Determine the duration of progression-free survival and overall survival of these patients.

II. Determine the effects of prognostic factors, including performance status and histological grade.

OUTLINE:

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Conditions

Recurrent Endometrial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (bevacizumab)

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: BIOLOGICAL

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

bevacizumab

Given IV

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

anti-VEGF humanized monoclonal antibody; anti-VEGF monoclonal antibody; Avastin; rhuMAb VEGF

Eligibility Criteria

Inclusion Criteria

• 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
• No serious nonhealing wound or ulcer, including any of the following:

• History of abdominal fistula
• Gastrointestinal perforation
• Intra-abdominal abscess within the past 28 days
• No serious nonhealing bone fracture
• No active bleeding or pathologic conditions that carry high risk of bleeding, including known bleeding disorder or coagulopathy
• No 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 arrhythmia requiring medication
• Ejection fraction < 50% and received prior anthracycline (including doxorubicin and/or doxorubicin HCl liposomal)
• Grade 2 or greater peripheral vascular disease
• History of cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
• No significant traumatic injury within the past 28 days
• See Disease Characteristics
• Recovered from recent surgery, radiotherapy, or chemotherapy
• Hormonal therapy directed at the malignant tumor must be discontinued ≥ 1 week prior to registration
• Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued ≥ 3 weeks prior to registration
• No prior chemotherapy or radiotherapy to any portion of the abdominal cavity or pelvis

• Prior chemotherapy or radiotherapy for localized cancer of the breast, head and neck, or skin for which the patient remains free of recurrent or metastatic disease is allowed provided it was completed ≥ 3 years prior to study
• No prior cancer treatment that contraindicates study therapy
• No prior bevacizumab or other vascular endothelial growth factor (VEGF) pathway-targeted therapy
• One additional prior cytotoxic regimen for recurrent or persistent endometrial cancer allowed, including any agent that targets the genetic and/or mitotic apparatus of dividing cells resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
• No prior noncytotoxic chemotherapy for recurrent or persistent disease
• More than 28 days since major surgical procedure or open biopsy
• More than 7 days since minor surgical procedures, fine needle aspirates, or core biopsies
• No concurrent major surgical procedure
• No concurrent prophylactic filgrastim (G-CSF) or thrombopoietic agents
• No concurrent amifostine or other protective reagents

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Aghajanian

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02692

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000465502

Identifier Type: -

Identifier Source: secondary_id

GOG-0229E

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0229E

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02692

Identifier Type: -

Identifier Source: org_study_id