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Endometrial AdenocarcinomaPhase 2NCT01005329

Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer

A Phase 2 study testing Bevacizumab, Carboplatin and Cisplatin in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 41 sites in 3 countries.

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 studies the side effects of giving intensity-modulated radiation therapy together with cisplatin and bevacizumab followed by carboplatin and cisplatin and to see how well they work in treating patients who have undergone surgery for high-risk endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab, Carboplatin and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
41 sitesin 3 countries
Study dates
6 Nov 2009to 22 Sep 2013
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 cancer, including 1 of the following cellular types:
  • Endometrioid endometrial adenocarcinoma
  • Clear cell carcinoma
  • Papillary serous adenocarcinoma
  • Adenosquamous cell carcinoma
  • Other adenocarcinoma variant
Show all 59Show fewer
  • No carcinosarcoma
  • Meets 1 of the following criteria:
  • Grade 3 carcinoma with > 50% myometrial invasion (stage IC or IIA) (all papillary serous or clear cell carcinoma will be considered grade 3)
  • Grade 2 or 3 carcinoma with any cervical stromal invasion (stage IIB)
  • Known extra-uterine disease confined to the pelvis (stage III or IVA)
  • Patients with stage III or IVA disease must have undergone computed tomography (CT) scan or positron emission tomography (PET)/CT scan of the abdomen and pelvis within the past 56 days
  • Has undergone hysterectomy (i.e., total abdominal, vaginal, robotic-assisted, radical, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy within the past 56 days
  • No positive common iliac or positive para-aortic nodal disease (defined as lymph nodes ? 2 cm in any dimension on CT scan or biopsy) or positive peritoneal cytology
  • No evidence of metastatic extrauterine disease, gross or residual disease (not including pelvic nodal disease), or distant metastases
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ? 1,500/mm^3 (without growth factor support)
  • Platelet count ? 100,000/mm^3
  • Hemoglobin ? 10 g/dL (transfusion allowed)
  • Total bilirubin ? 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2 times ULN
  • Serum creatinine ? 1.5 mg/dL
  • Urine protein:creatinine ratio ? 0.5 OR urine protein < 1,000 mg on 24-hour urine collection
  • International normalized ratio (INR) < 1.5 (for patients treated with warfarin within the past 14 days)
  • Not nursing
  • No neuropathy ? Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • No ototoxicity > CTCAE grade 2
  • No serious, active comorbidity, including any of the following:
  • Unstable angina and/or New York Heart Association (NYHA) class II-IV congestive heart failure requiring hospitalization within the past 12 months
  • Transmural myocardial infarction within the past 12 months
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition (human immunodeficiency virus [HIV] testing is not required)
  • Active gastrointestinal (GI) ulcers, GI bleeding, inflammatory bowel disease, or GI obstruction
  • Inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 90 mm Hg on antihypertensive medications
  • Significant vascular disease, including aortic aneurysm, aortic dissection, or arteriovenous malformation within the past 12 months
  • Serious cardiac arrhythmia on medication (well-controlled atrial fibrillation on medication allowed)
  • Serious non-healing wound, ulcer, or bone fracture
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No stroke/cerebrovascular event within the past 12 months
  • No arterial thromboembolic events, including transient ischemic attack or clinically symptomatic peripheral artery disease within the past 12 months
  • No abdominal fistula, GI perforation, or intra-abdominal abscess within the past 6 months
  • No other invasive malignancies within the past 3 years other than nonmelanomatous skin cancer
  • No significant trauma within the past 28 days
  • No mental status changes or bladder problems that would preclude the ability to comply with bladder-filling instructions
  • No mental or psychiatric illness that would preclude giving informed consent
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No prior allergic reaction to bevacizumab, cisplatin, carboplatin, or paclitaxel
  • No concurrent erythropoietin, St. John's wort, therapeutic anticoagulants, aminoglycoside antibiotics, or amifostine
  • No prior organ transplantation
  • No prior external-beam radiotherapy to the pelvis resulting in overlapping of radiotherapy fields
  • No prior systemic chemotherapy for uterine cancer
  • Prior chemotherapy for a different cancer is allowed
  • No prior therapy with anti-vascular endothelial growth factor (VEGF) compounds
  • More than 28 days since prior major surgical procedure requiring open biopsy incision
  • No concurrent surgery (except for vascular access device placement or procedures that do not require significant incision)
  • No concurrent warfarin at doses > 1 mg/day
  • Concurrent prophylactic low molecular weight heparin allowed

Who cannot join

None listed.

Trial locations and contacts

41 sites in 3 countries.

41 sites in 3 countries

United States38 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network-Southside Cancer Center

    Jacksonville, Florida, 32207

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network-Florida Cancer Center Beaches

    Jacksonville Beach, Florida, 32250

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Elliot Hospital

    Manchester, New Hampshire, 03103

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • 21st Century Oncology-Orange Park

    Orange Park, Florida, 32073

  • 21st Century Oncology-Palatka

    Palatka, Florida, 32177

  • Bay Medical Center

    Panama City, Florida, 32401

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Radiation Therapy Oncology Group

    Philadelphia, Pennsylvania, 19103

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Integrated Community Oncology Network-Flager Cancer Center

    Saint Augustine, Florida, 32086

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Flower Hospital

    Sylvania, Ohio, 43560

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598

  • Wheeling Hospital/Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada2 sites

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

Other trials in Canada

Hong Kong1 site

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

Other trials in Hong Kong

About this study

Official title: A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer

This phase II trial studies the side effects of giving intensity-modulated radiation therapy together with cisplatin and bevacizumab followed by carboplatin and cisplatin and to see how well they work in treating patients who have undergone surgery for high-risk endometrial cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving intensity-modulated radiation therapy together with chemotherapy and bevacizumab after surgery may kill any tumor cells that remain after surgery.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the treatment-related, grade 3+, non-hematologic adverse-event rate within 90 days from the start of treatment with concurrent intensity-modulated radiotherapy, cisplatin, and bevacizumab followed by carboplatin and paclitaxel in patients with high-risk endometrial cancer.

SECONDARY OBJECTIVES:

  1. To evaluate treatment-related adverse events occurring within 1 year from the start of treatment.

II. To evaluate all treatment-related adverse events. III. To evaluate disease-free and overall survival. IV. To evaluate local, regional, and distant failure.

OUTLINE:

Patients undergo pelvic intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Patients also receive concurrent cisplatin intravenously (IV) over 1 hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Being tested
Bevacizumab, Carboplatin, Cisplatin, Intensity-Modulated Radiation Therapy, Paclitaxel

What participants receive

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

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

Study groups in NCT01005329
Study groupRoleWhat they receive
Treatment (IMRT, cisplatin,bevacizumab,carboplatin,paclitaxel)ExperimentalPatients undergo pelvic IMRT once daily, 5 days a week, for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Drug: Carboplatin; Drug: Cisplatin; Radiation: Intensity-Modulated Radiation Therapy; Drug: Paclitaxel

What is being measured

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

  1. Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start

    Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Measured: From start of treatment to 90 days

Secondary outcomes (6)

  1. Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start

    Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events reported as definitely, probably, or possibly related to study treatment.

    Measured: From start of treatment to one year

  2. Treatment-related Grade 3+ Adverse Events

    The highest grade adverse event per patient reported as definitely, probably, or possibly related to study treatment is counted. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Measured: From start of treatment to end of follow-up, up to 43.4 months; analysis occurred after all patients had been on study for at least one year.

  3. Overall Survival (Two-year Rate Reported)

    Failure was defined as death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Survival rate at two years was estimated using the Kaplan-Meier method.

    Measured: From registration to two years

  4. Disease-free Survival (Two-year Rate Reported)

    Failure was defined as pelvic failure (recurrence in the pelvis, which must be confirmed by histologic or cytologic biopsy of the recurrent lesion), distant failure (confirmed by histologic or cytologic biopsy of the recurrent lesion), or death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Disease-free survival rate at two years was estimated using the Kaplan-Meier method.

    Measured: From registration to two years

  5. Pelvic Failure Rate (Two-year Rate Reported)

    Pelvic failure (PF) was defined as disease recurrence in the pelvis, including the pelvic or sacral lymph nodes, and required confirmation by histologic or cytologic biopsy of the recurrent lesion. Death was considered a competing risk. PF rates were estimated using the cumulative incidence method.

    Measured: From registration to two years

  6. Distant Failure (Two-year Rate Reported)

    Distant Failure (DF) was defined as the appearance of distant metastasis. Death was considered a competing risk. DF rates were estimated using the cumulative incidence method.

    Measured: From registration to two years

Timeline

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

  1. First posted30 Oct 2009 (estimated)
  2. Study start6 Nov 2009
  3. Primary completion30 Jun 2012
  4. Study completion22 Sep 2013

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01005329
Sponsor's protocol ID
NCI-2011-01982
Other IDs
NCI-2011-01982, CDR0000657979, RTOG-0921, RTOG 0921, RTOG-0921, U10CA021661
Status last verified
Feb 2018
First submitted
29 Oct 2009
Last updated
15 Mar 2018

Publications

  • Viswanathan AN, Moughan J, Miller BE, Xiao Y, Jhingran A, Portelance L, Bosch WR, Matulonis UA, Horowitz NS, Mannel RS, Souhami L, Erickson BA, Winter KA, Small W Jr, Gaffney DK. NRG Oncology/RTOG 0921: A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer. Cancer. 2015 Jul 1;121(13):2156-63. doi: 10.1002/cncr.29337. Epub 2015 Apr 6.

    PubMed 25847373

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Carboplatin and Cisplatin in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 41 sites in 3 countries.

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 59 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 15 Mar 2018. 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, Canada, Hong Kong. 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 24 Feb 2014). 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?

Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start (time frame: From start of treatment to 90 days). 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 NCT01005329, which also lists 1 linked publication.

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 15 Mar 2018.

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