AzTrials
AzTrials

Recurrent Endometrial CarcinomaPhase 2NCT00301964

Bevacizumab in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase 2 study testing bevacizumab and laboratory biomarker analysis in people with Recurrent Endometrial Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Endometrial Carcinoma
What is being tested?
bevacizumab and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Mar 2006to Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 56Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Evaluation of Bevacizumab (NCI-Supplied Agent: NSC# 704865, IND # 7921) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
bevacizumab, laboratory biomarker analysis
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00301964
Study groupRoleWhat they receive
Treatment (bevacizumab)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: bevacizumab; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival Greater Than 6 Months

    Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

    Measured: 6 months

  2. Best Tumor Response

    Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):

    Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.

    Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

    Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

    Stable Disease is any condition not meeting the above criteria.

    Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

    Measured: study entry through completion

  3. Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Progression-free Survival

    Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

    Measured: Every other cycle for the first 6 months; then every 4 cycles until progression or death, up to 5 years.

  2. Overall Survival

    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

    Measured: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

  3. Initial Performance Status

    Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.

    Measured: Baseline

  4. Histologic Grade

    G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301964
Sponsor's protocol ID
NCI-2012-02692
Other IDs
NCI-2012-02692, CDR0000465502, GOG-0229E, GOG-0229E, U10CA027469
Status last verified
Jul 2019
First submitted
9 Mar 2006
Last updated
24 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and laboratory biomarker analysis in people with Recurrent Endometrial Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 56 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival Greater Than 6 Months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00301964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in