Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

NCT01210222 | Completed Phase 2 Results DMC

• 5 other identifiers: GOG-0229LNCI-2011-02655CDR0000686066U10CA180868U10CA027469
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 33

Brief Summary

This phase II trial studies the side effects and how well trebananib works in treating patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of endometrial cancer by blocking blood flow to the tumor.

Conditions

Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation; Endometrial Serous Adenocarcinoma; Endometrioid Stromal Sarcoma; Recurrent Uterine Corpus Carcinoma

Outcome Measures

Primary Outcomes (3)

• Progression-free Survival > 6 Months

  Whether or not the patient survived progression-free for at least 6 months.

  At 6 months

• Objective Tumor Response (Complete or Partial Response)

  Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Up to 5 years

• Adverse Events as Assessed by NCI CTCAE v 4.0

  Up to 5 years

Secondary Outcomes (2)

• Overall Survival

  From study entry to death or last contact, up to 5 years

• Progression-free Survival

  Patients whose disease can be evaluated by physical exam, progression was assessed prior to each cycle. CT or MRI if used to follow leasion for measurable disease, up to 5 years

Study Arms (1)

Treatment (trebananib)

EXPERIMENTAL

Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: Trebananib

Interventions

Trebananib BIOLOGICAL

Given IV

Treatment (trebananib)

Eligibility Criteria

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

You may qualify if:

• Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required; stained slides to document the primary tumor as well as recurrent/persistent disease (if documented by histology or cytology) are required
• Patients with the following histologic epithelial cell types are eligible:
• Endometrioid adenocarcinoma
• Serous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Adenocarcinoma not otherwise specified (N.O.S.)
• Mucinous adenocarcinoma
• Squamous cell carcinoma
• Transitional cell carcinoma
• All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
• Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as 'non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence \>= 90 days following completion of radiation therapy
• Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III or Rare Tumor protocol for the same patient population
• Patients who have received one prior chemotherapy regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior chemotherapy regimens must have a GOG performance status of 0 or 1

You may not qualify if:

• Patients who are currently or have been previously treated with trebananib, or other molecules that inhibit the angiopoietins or Tie2 receptor
• Patient with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
• Patients who are pregnant or nursing
• Patients with symptoms of partial or complete bowel obstruction; recent (within 6 months) history of fistula, intraabdominal abscess or bowel perforation; subjects requiring total parenteral nutrition or parenteral hydration
• Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases
• Patients with clinically significant cardiovascular disease; this includes:
• Myocardial infarction or unstable angina within 12 months of the first date of study treatment
• New York Heart Association (NYHA) Class II or greater congestive heart failure
• History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
• Grade 2 or greater peripheral vascular disease
• Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of study treatment
• History of arterial ischemia or thrombus
• Patients with uncontrolled hypertension defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg; the use of anti-hypertensive medications to control hypertension is permitted

Sponsors & Collaborators

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

Study Sites (33)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Memorial University Medical Center

Savannah, Georgia, 31404, 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

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States

Location

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, 50010, 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

Maine Medical Center-Bramhall Campus

Portland, Maine, 04102, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem, North Carolina, 27104, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, 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

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Sarcoma, Endometrial Stromal

Interventions

trebananib

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Endometrial Stromal Tumors; Sarcoma; Neoplasms, Connective and Soft Tissue; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases

Results Point of Contact

• Title: Linda Gedeon for Michael Sill, PhD.
• Organization: NRG Oncology

lgedeon@gogstats.org

716-845-1169

Study Officials

• Kathleen Moore

  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: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2010
• First Posted: September 28, 2010
• Study Start: June 6, 2011
• Primary Completion: July 16, 2016
• Study Completion: July 16, 2016
• Last Updated: February 23, 2018
• Results First Posted: November 29, 2017

Record last verified: 2017-08

Locations

US (33)