Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT01011933 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2011-01958GOG-0229HCDR0000651456U10CA180868U10CA027469
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 72

Brief Summary

This phase II trial is studying how well selumetinib works in treating patients with recurrent or persistent endometrial cancer that has come back or is persistent. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Recurrent Uterine Corpus Carcinoma

Outcome Measures

Primary Outcomes (3)

• Number of Participants With or Without Progression-free Survival for > 6 Months by Response Evaluation Criteria for Solid Tumors (RECIST)

  Number of participants who survived progression-free for more than 6 months. Progression is defined using Response Evaluation Criteria for Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions in the opinion of the treating physician, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression.

  > 6 months from study entry

• Objective Tumor Response Rate Assessed by RECIST

  Per Response Evaluation Criteria In Solid Tumors (RECIST) Criteria: 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. Normalization of CA125, if elevated at study entry, is required; 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; Increasing Disease 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.

  From study entry, assessed up to 5 years

• Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0

  Each cycle during treatment and 30 days after the last treatment.

Secondary Outcomes (2)

• Duration of Progression-free Survival

  Every other cycle for the first 6 months; then every 3 months thereafter for 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.

Other Outcomes (2)

• Number of Participants Off Study Therapy for Each Reason Specified.

  from study entry until end of study treatment, up to 5 years.

• Patient Vital Status

  Study entry up to 2 years

Study Arms (1)

Treatment (selumetinib)

EXPERIMENTAL

Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.

Other: Diagnostic Laboratory Biomarker Analysis; Drug: Selumetinib

Interventions

Diagnostic Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (selumetinib)

Selumetinib DRUG

Given PO

Also known as: ARRY-142886, AZD6244, MEK Inhibitor AZD6244

Treatment (selumetinib)

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 epithelial carcinoma, including any of the following cell types:
• Endometrioid adenocarcinoma
• Serous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Adenocarcinoma not otherwise specified
• Mucinous adenocarcinoma
• Squamous cell carcinoma
• Transitional cell carcinoma
• Mesonephric carcinoma
• Recurrent or persistent disease that is refractory to curative therapy or established treatments
• Measurable disease, defined as ≥ 1 lesion that can be measured in ≥ 1 dimension (longest dimension to be recorded)
• Each lesion must be ≥ 20 mm when measured by conventional techniques (palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm when measured by spiral CT scan
• Must have ≥ 1 target lesion to be used to assess response, as defined by RECIST criteria

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• NRG Oncology: collaborator

Study Sites (72)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

MedStar Washington Hospital Center

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

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Hinsdale, Illinois, 60521, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Saint Vincent Oncology Center

Indianapolis, Indiana, 46260, United States

Location

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, 50325, United States

Location

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, 50314, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Methodist West Hospital

West Des Moines, Iowa, 50266-7700, United States

Location

Mercy Medical Center-West Lakes

West Des Moines, Iowa, 50266, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Saint Luke's South Hospital

Overland Park, Kansas, 66213, United States

Location

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, 66208, United States

Location

MedStar Franklin Square Medical Center/Weinberg Cancer Institute

Baltimore, Maryland, 21237, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

Michigan Cancer Research Consortium CCOP

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Hospital and Medical Center

Dearborn, Michigan, 48124, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48502, United States

Location

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Saint Joseph Mercy Port Huron

Port Huron, Michigan, 48060, United States

Location

Saint Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, 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

Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, 64118, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States

Location

Liberty Hospital

Liberty, Missouri, 64068, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Saint Joseph Oncology Inc

Saint Joseph, Missouri, 64507, United States

Location

Cancer Research for the Ozarks NCORP

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

State University of New York Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Main Line Health NCORP

Wynnewood, Pennsylvania, 19096, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026-1967, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Coleman RL, Sill MW, Thaker PH, Bender DP, Street D, McGuire WP, Johnston CM, Rotmensch J. A phase II evaluation of selumetinib (AZD6244, ARRY-142886), a selective MEK-1/2 inhibitor in the treatment of recurrent or persistent endometrial cancer: an NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2015 Jul;138(1):30-5. doi: 10.1016/j.ygyno.2015.04.005. Epub 2015 Apr 14.

  PMID: 25887099 DERIVED

MeSH Terms

Interventions

AZD 6244

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

  NRG Oncology

  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: November 10, 2009
• First Posted: November 11, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 23, 2019
• Results First Posted: January 20, 2014

Record last verified: 2019-07

Locations

US (72)