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Recurrent Endometrial CarcinomaPhase 2NCT00462826

VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase 2 study testing ziv-aflibercept in people with Recurrent Endometrial Carcinoma, run by National Cancer Institute (NCI) at 67 sites 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 the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells. 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?
ziv-aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
67 sitesUnited States
Study dates
Nov 2007to Jan 2013
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

  • Histologically confirmed endometrial carcinoma, meeting both of the following criteria:
  • Recurrent or persistent disease
  • Refractory to curative therapy or established treatments
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Tumors within a previously irradiated field are designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy
  • Must have received one prior chemotherapeutic regimen for management of endometrial carcinoma (initial treatment may include high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment)
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  • Not a candidate for a higher priority GOG protocol
  • No history or evidence of primary brain tumor or brain metastases
  • GOG performance status (PS) 0-2 (patients who received 1 prior regimen) OR GOG PS 0-1 (patients who received 2 prior regimens)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Urine protein:creatinine ratio < 1.0 OR urine protein < 1.0 g by 24-hour urine collection
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • PT/PTT/INR ≤ 1.5 times ULN
  • In-range INR (between 2 and 3) allowed if patient is on a stable dose of therapeutic warfarin
  • QTc < 500 msec
  • No evidence of serious ventricular arrhythmia
  • Ventricular tachycardia or ventricular fibrillation must be < 3 beats in a row
  • LVEF normal
  • Ejection fraction ≥ 50% (for patients who received prior anthracycline, including doxorubicin hydrochloride and/or doxorubicin hydrochloride liposome)
  • No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg
  • Myocardial infarction or unstable angina within the past 6 months
  • NYHA class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Peripheral vascular disease ≥ grade 2
  • Cerebrovascular accident (i.e., CVA or stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
  • No HIV positivity
  • No neuropathy (sensory and motor) > grade 1
  • No active infection requiring antibiotics
  • No other invasive malignancies or any evidence of other cancer within the past 5 years except for nonmelanoma skin cancer
  • No serious nonhealing wound, ulcer, or bone fracture
  • No history of abdominal fistula or gastrointestinal perforation
  • No history or evidence of seizures not controlled with standard medical therapy
  • No intra-abdominal abscess within the past 28 days
  • No active bleeding or pathologic conditions that carry a high risk of bleeding (e.g., bleeding disorder, coagulopathy, or tumor involving major vessels)
  • 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
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Recovered from prior surgery
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
  • At least 1 week since prior hormonal therapy
  • Concurrent hormone replacement therapy allowed
  • At least 3 weeks since any other prior therapy, including immunologic agents
  • One additional prior cytotoxic regimen for management of recurrent or persistent endometrial cancer allowed
  • Cytotoxic regimens include 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
  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior minor surgery, fine needle aspirates, or core biopsies
  • No prior cancer treatment that would preclude study compliance
  • No prior noncytotoxic chemotherapy for management of recurrent or persistent endometrial disease
  • No prior VEGF Trap or other VEGF pathway-targeted therapy
  • More than 5 years since prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of endometrial cancer
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
  • Patient must remain free of recurrent or metastatic disease
  • More than 5 years since prior chemotherapy for any abdominal or pelvic tumor except for the treatment of endometrial cancer
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer
  • Patient must remain free of recurrent or metastatic disease
  • Concurrent low-molecular weight heparin allowed for the prevention or treatment of venous thromboembolic disease if condition is considered clinically stable with treatment
  • No other concurrent investigational agents
  • No concurrent major surgery

Who cannot join

None listed.

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Southwest Gynecologic Oncology Associates Inc

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Gynecologic Oncology Network

    Greenville, North Carolina, 27834

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Saint Vincent Hospital and Health Services

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Radiation Oncology Practice Corporation South

    Kansas City, Missouri, 64114

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Radiation Oncology Practice Corporation - North

    Kansas City, Missouri, 64154

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Liberty Hospital

    Liberty, Missouri, 64068

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Radiation Oncology Center of Olathe

    Olathe, Kansas, 66061

  • Florida Hospital

    Orlando, Florida, 32803

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Radiation Oncology Practice Corporation Southwest

    Overland Park, Kansas, 66210

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Cancer Care Associates-Midtown

    Tulsa, Oklahoma, 74104

  • Tulsa Cancer Institute

    Tulsa, Oklahoma, 74146

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Evaluation of VEGF-Trap (AFLIBERCEPT, NSC #724770, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial cancer, in terms of the frequency of patients who have progression-free survival for at least 6 months after initiating therapy or have objective tumor response.

II. Determine the toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

  1. Determine the duration of progression-free survival and overall survival of patients treated with this drug.

OUTLINE:

Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Being tested
ziv-aflibercept
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • ziv-afliberceptBiological

    Also called aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap

Study groups in NCT00462826
Study groupRoleWhat they receive
Treatment (aflibercept)ExperimentalPatients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: ziv-aflibercept

What is being measured

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

  1. 6 Month Progression-free Survival

    Number of participants who survived progression-free for more than 6 months.

    Measured: At 6 monthsEvery other cycle during treatment for the first 6 months.

  2. Objective Tumor Response (RECIST 1.0)

    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

    Measured: Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.

  3. Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

    Adverse events at least possibly related to the study agent.

    Measured: Assessed every cycle while on treatment, 30 days after the last cycle of treatment

Secondary outcomes (2)

  1. Duration of 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 during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.

  2. Duration of 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.

Timeline

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

  1. First posted19 Apr 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJan 2013
  4. Study completionJan 2013

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
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462826
Sponsor's protocol ID
NCI-2009-00597
Other IDs
NCI-2009-00597, CDR0000540237, GOG-0229F, GOG-0229F, U10CA027469
Status last verified
Jul 2019
First submitted
18 Apr 2007
Last updated
23 Jul 2019

Publications

  • Coleman RL, Sill MW, Lankes HA, Fader AN, Finkler NJ, Hoffman JS, Rose PG, Sutton GP, Drescher CW, McMeekin DS, Hu W, Deavers M, Godwin AK, Alpaugh RK, Sood AK. A phase II evaluation of aflibercept in the treatment of recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Dec;127(3):538-43. doi: 10.1016/j.ygyno.2012.08.020. Epub 2012 Aug 23.

    PubMed 22922531

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ziv-aflibercept in people with Recurrent Endometrial Carcinoma, run by National Cancer Institute (NCI) at 67 sites 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 66 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 23 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 67 sites 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 16 Sep 2013). 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?

6 Month Progression-free Survival (time frame: At 6 monthsEvery other cycle during treatment for the first 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 NCT00462826, which also lists 1 linked publication.

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 23 Jul 2019.

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