Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00301964
First received: March 9, 2006
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Recurrent Endometrial Carcinoma
Biological: bevacizumab
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Bevacizumab (NCI-Supplied Agent: NSC# 704865, IND # 7921) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency of patients who survive progression-free [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency of patients who have objective tumor response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessed using GOG RECIST criteria.

  • Frequency of adverse effects [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Severity of adverse events as assessed by CTCAE version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Characterized graphically and using descriptive statistics.

  • Overall survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Characterized graphically and using descriptive statistics.

  • Initial performance status and histological grade [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2007
Primary Completion Date: July 2011 (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. Treatment repeats every 3 weeks 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
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00301964

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Carol Aghajanian Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00301964     History of Changes
Other Study ID Numbers: NCI-2012-02692, NCI-2012-02692, CDR0000465502, GOG-0229E, GOG-0229E, U10CA027469
Study First Received: March 9, 2006
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
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 July 26, 2014