AzTrials
AzTrials

Recurrent Endometrial CarcinomaPhase 2NCT00723255

Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase 2 study testing bevacizumab and temsirolimus in people with Recurrent Endometrial Carcinoma, run by National Cancer Institute (NCI) at 41 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 of giving bevacizumab together with temsirolimus and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. 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?
bevacizumab and temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
41 sitesUnited States
Study dates
Sep 2008to 25 Jan 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

  • Histologically confirmed endometrial carcinoma (from primary tumor) including any of the following cell types:
  • Endometrioid adenocarcinoma
  • Serous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Mixed epithelial carcinoma
Show all 70Show fewer
  • 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 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have ≥ 1 target lesion to assess response as defined by RECIST
  • Tumors within a previously irradiated field are designated as "non-target" lesions in the absence of documented disease progression or a biopsy to confirm persistence for ≥ 90 days after completion of radiotherapy
  • Must have received 1 prior chemotherapeutic regimen for management of endometrial carcinoma
  • May have received 1 additional cytotoxic regimen for management of this disease
  • Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, including any active GOG Phase III protocol for patients with endometrial carcinoma
  • No history or evidence of CNS disease, including primary brain tumor or any brain metastases upon physical examination
  • GOG performance status (PS) 0-2 (for patients who have received 1 prior regimen) OR PS 0-1 (for patients who have received 2 prior regimens)
  • ANC ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • 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
  • Urine protein:creatinine ratio < 1.0 OR urine protein < 1,000 mg by 24-hour urine collection
  • INR ≤ 1.5 OR in-range INR between 2 and 3 if patient is on a stable dose of therapeutic warfarin
  • PTT ≤ 1.5 times ULN
  • Fasting cholesterol < 350 mg/dL
  • Fasting triglycerides < 400 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Seizures allowed provided they are controlled with standard medical therapy
  • No active infection requiring antibiotics, except uncomplicated urinary tract infection
  • No active bleeding or pathologic conditions that carry high risk of bleeding, (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)
  • No serious, non-healing wound, ulcer, or bone fracture, including abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 3 months
  • No prior underlying lesions that caused the fistula or perforation that have not been corrected
  • No prior interstitial pneumonitis
  • No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg
  • Myocardial infarction or unstable angina within the past 6 months
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Peripheral vascular disease ≥ grade 2
  • No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
  • No uncontrolled diabetes
  • Hemoglobin A1C < 10
  • No other invasive malignancies within the past 5 years, except nonmelanoma skin cancer and other specific malignancies (e.g., localized breast, head and neck, or skin cancer that completed treatment > 3 years prior to study and remain disease-free)
  • No significant traumatic injury within the past 28 days
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Concurrent prophylactic or therapeutic anticoagulation* (e.g., warfarin) allowed
  • Recovered from recent surgery, radiotherapy, or chemotherapy
  • No prior bevacizumab or other VEGF pathway-targeted therapy
  • No prior temsirolimus, everolimus, deforolimus, sirolimus, or any other mTor/PI3K pathway-targeted therapy
  • No prior non-cytotoxic chemotherapy for management of this disease, except hormonal therapy
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • No prior therapy that contraindicates this protocol therapy
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis within the past 5 years, except treatment of endometrial cancer
  • Prior radiotherapy for localized cancer of the breast, head and neck, or skin is allowed, provided it was completed > 3 years prior to study entry and patient remains free of recurrent or metastatic disease
  • No prior chemotherapy for any abdominal or pelvic tumor within the past 5 years, except treatment of endometrial cancer
  • Prior adjuvant chemotherapy for localized breast cancer allowed, provided it was completed > 3 years prior to study entry and the patient remains free of recurrent or metastatic disease
  • Prior treatment with an anthracycline (i.e., doxorubicin and/or liposomal doxorubicin) allowed provided ejection fraction < 50%
  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since minor surgical procedures, fine needle aspirates, or core biopsies
  • At least 3 weeks since prior therapy directed at the malignant tumor, including immunologic agents
  • No concurrent major surgery
  • No concurrent prophylactic filgrastim (G-CSF) or thrombopoietic agents
  • No concurrent amifostine or other protective reagents

Who cannot join

None listed.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Women's Cancer Care Associates LLC

    Albany, New York, 12208

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Gynecologic Oncology of West Michigan PLLC

    Grand Rapids, Michigan, 49546

  • Gynecologic Oncology Network

    Greenville, North Carolina, 27834

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Sudarshan K Sharma MD Limted-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Services

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545-1470

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield

    Springfield, Missouri, 65804

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • 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 Combination Bevacizumab (NCI-Supplied Agent: NSC #70486) and Temsirolimus (CCI-779, NCI-Supplied Agent, NSC #683864) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

This phase II trial is studying the side effects of giving bevacizumab together with temsirolimus and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving bevacizumab together with temsirolimus may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the activity of bevacizumab and temsirolimus, in terms of 6-month progression-free survival (PFS) and objective tumor response, in patients with recurrent or persistent endometrial cancer.

II. To determine the nature and degree of toxicity of this regimen in these patients.

SECONDARY OBJECTIVES:

  1. To determine the duration of PFS and overall survival of patients treated with this regimen.

II. To determine the effects of prognostic factors (i.e., performance status, histological subtype, and grade) in patients treated with this regimen.

TERTIARY OBJECTIVES:

  1. To compare the proportion of patients with objective tumor response and PFS at 6 months receiving the combination of bevacizumab and temsirolimus with those for the single agents bevacizumab and temsirolimus using historical controls.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 3 years, for a total of 5 years.

Being tested
bevacizumab, temsirolimus
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

Study groups in NCT00723255
Study groupRoleWhat they receive
Treatment (bevacizumab, temsirolimus)ExperimentalPatients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22.
Receives: Biological: bevacizumab; Drug: temsirolimus

What is being measured

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

  1. Tumor Response

    Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0

    Measured: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease

  2. Progression-free Survival at 6 Months

    Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

    Measured: Every other cycle for 6 months

  3. Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

    Measured: Every cycle and 30 days after the last treatment, an average of 5 years.

Secondary outcomes (8)

  1. Progression-Free Survival

    Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

    Measured: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.

  2. Overall Survival

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

    Measured: From entry into the study to death or the date of last contact, up to 5 years

  3. Complete and Partial Tumor Response by RECIST 1.0 by Performance Status

    Complete and Partial Tumor Response by RECIST 1.0

    Measured: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease

  4. Progression-free Survival at 6 Months by Performance Status

    Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

    Measured: Every other cycle for 6 months

  5. Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type

    Complete and Partial Tumor Response by RECIST 1.0

    Measured: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease

  6. Progression-free Survival at 6 Months by Histologic Type

    Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

    Measured: Every other cycle for 6 months

  7. Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade

    Complete and Partial Tumor Response by RECIST 1.0

    Measured: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease

  8. Progression-free Survival at 6 Months by Tumor Grade

    Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

    Measured: Every other cycle for 6 months

Timeline

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

  1. First posted28 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completion15 Jul 2011
  4. Study completion25 Jan 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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00723255
Sponsor's protocol ID
NCI-2009-00598
Other IDs
NCI-2009-00598, CDR0000601291, GOG-0229G, GOG-0229G, U10CA027469
Status last verified
Jul 2019
First submitted
25 Jul 2008
Last updated
23 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and temsirolimus in people with Recurrent Endometrial Carcinoma, run by National Cancer Institute (NCI) at 41 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 70 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 41 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 5 Aug 2015). 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?

Tumor Response (time frame: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease). 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 NCT00723255.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in