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Endometrial AdenocarcinomaPhase 2NCT01210222

Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

A Phase 2 study testing Trebananib in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 33 sites in United States.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Trebananib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
33 sitesUnited States
Study dates
6 Jun 2011to 16 Jul 2016
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

  • 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
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  • 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
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
  • Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration
  • Any prior radiation therapy must be completed at least 4 weeks prior to registration
  • Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a chemotherapy regimen
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
  • Patients must have NOT received any non-cytotoxic (biologic or targeted) agents as part of their primary treatment or for management of recurrent or persistent disease
  • Non-cytotoxic (biologic or targeted) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
  • Prior hormonal therapy is allowed; there is no limit on the number of prior hormonal therapies allowed
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Hemoglobin level >= 9.0 g/dL
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) or a creatinine clearance >= 60 ml/m^2
  • Bilirubin less than or equal to 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Neuropathy (sensory and motor) less than or equal to grade 1
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 x ULN
  • Albumin >= 2.8 mg/dL
  • Patients must have a urine protein of =< 1 on dipstick; if dipstick is 2+ or higher, 24-hour urine protein must be obtained and should be < 1 g for patient to be eligible
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients of child bearing potential must agree to use an accepted and effective non-hormonal method of contraception i.e., double barrier method (e.g. condom plus diaphragm) from the time of signing the informed consent through 6 months after last dose of study drug

Who cannot join

  • 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
Show all 27Show fewer
  • 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
  • Patients with significant bleeding within 6 months of enrollment or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients who have undergone major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of study treatment or who have major surgical procedure anticipated during the course of the study
  • Patients who have undergone minor surgical procedures within 7 days of the first date of study treatment
  • Paracentesis and thoracentesis are permitted prior to and while on study at the discretion of the investigator and as clinically indicated
  • Patients treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment
  • Patients with serious non-healing wound, ulcer (including gastrointestinal), or bone fracture
  • Patients with known human immunodeficiency virus (HIV), hepatitis C or chronic or active hepatitis B
  • Patients with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation
  • Patients not available for follow-up assessments
  • Patients with known sensitivity to any of the products to be administered during dosing
  • Patients with history of allergic reactions to bacterially produced proteins
  • Patients with a history of venous or arterial thromboembolism within 12 months prior to enrollment/randomization

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Sudarshan K Sharma MD Limted-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Maine Medical Center-Bramhall Campus

    Portland, Maine, 04102

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: A Phase II Trial of AMG 386, a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients With Persistent/Recurrent Carcinoma of the Endometrium

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with AMG 386 (trebananib).

II. To determine the nature and degree of toxicity of AMG 386 in this cohort of patients.

SECONDARY OBJECTIVES:

  1. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with AMG 386.

OUTLINE:

Patients receive trebananib intravenously (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.

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

Being tested
Trebananib
Medical subject headings
Sarcoma, Endometrial Stromal

What participants receive

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

  • TrebananibBiological

    Given IV

Study groups in NCT01210222
Study groupRoleWhat they receive
Treatment (trebananib)ExperimentalPatients 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.
Receives: Biological: Trebananib

What is being measured

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

  1. Progression-free Survival > 6 Months

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

    Measured: At 6 months

  2. 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.

    Measured: Up to 5 years

  3. Adverse Events as Assessed by NCI CTCAE v 4.0

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Overall Survival

    The observed length of life from entry into the study to death or the date of last contact.

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

  2. Progression-free Survival

    The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: 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

Timeline

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

  1. First posted28 Sep 2010 (estimated)
  2. Study start6 Jun 2011
  3. Primary completion16 Jul 2016
  4. Study completion16 Jul 2016

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01210222
Sponsor's protocol ID
GOG-0229L
Other IDs
NCI-2011-02655, CDR0000686066, GOG-0229L, GOG-0229L, U10CA180868, U10CA027469
Status last verified
Aug 2017
First submitted
25 Sep 2010
Last updated
23 Feb 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trebananib in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 33 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 38 inclusion and 27 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 29 Nov 2017). 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 > 6 Months (time frame: At 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 NCT01210222.

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 Feb 2018.

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