VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT00462826 | Completed Phase 2 Results

• 4 other identifiers: NCI-2009-00597CDR0000540237GOG-0229FU10CA027469
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 67

Brief 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.

Conditions

Recurrent Endometrial Carcinoma

Outcome Measures

Primary Outcomes (3)

• 6 Month Progression-free Survival

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

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

• 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.

  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.

• 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.

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

Secondary Outcomes (2)

• Duration of Progression-free Survival

  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.

• Duration of Overall Survival

  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.

Study Arms (1)

Treatment (aflibercept)

EXPERIMENTAL

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.

Biological: ziv-aflibercept

Interventions

ziv-aflibercept BIOLOGICAL

Also known as: aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap

Treatment (aflibercept)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (67)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31403, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Providence Medical Center

Kansas City, Kansas, 66112, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Radiation Oncology Center of Olathe

Olathe, Kansas, 66061, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Radiation Oncology Practice Corporation Southwest

Overland Park, Kansas, 66210, United States

Location

Shawnee Mission Medical Center

Shawnee Mission, Kansas, 66204, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Green Bay Oncology - Escanaba

Escanaba, Michigan, 49431, United States

Location

Green Bay Oncology - Iron Mountain

Iron Mountain, Michigan, 49801, United States

Location

Centerpoint Medical Center LLC

Independence, Missouri, 64057, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Radiation Oncology Practice Corporation South

Kansas City, Missouri, 64114, United States

Location

Saint Joseph Health Center

Kansas City, Missouri, 64114, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Radiation Oncology Practice Corporation - North

Kansas City, Missouri, 64154, United States

Location

Liberty Hospital

Liberty, Missouri, 64068, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Southwest Gynecologic Oncology Associates Inc

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Gynecologic Oncology Network

Greenville, North Carolina, 27834, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Mount Carmel Health Center West

Columbus, Ohio, 43222, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates-Midtown

Tulsa, Oklahoma, 74104, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74146, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, 24016, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Northwest Medical Specialties PLLC

Tacoma, Washington, 98405, United States

Location

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Green Bay Oncology - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

Related Publications (1)

• 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.

  PMID: 22922531 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Melissa Leventhal
• Organization: Gynecologic Oncology Group Statistical and Data Center

mleventhal@gogstats.org

716-845-4030

Study Officials

• Robert Coleman

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 23, 2019
• Results First Posted: September 16, 2013

Record last verified: 2019-07

Locations

US (67)