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



Status:Completed
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/29/2017
Start Date:September 2008
End Date:January 25, 2016

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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.

PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.

Inclusion Criteria:

- 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

- 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
We found this trial at
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615 N Michigan St
South Bend, Indiana 46601
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1000 Blythe Blvd
Charlotte, North Carolina 28203
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5801 South Ellis Avenue
Chicago, Illinois 60637
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2500 N State St
Jackson, Mississippi 39216
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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1200 Old York Road
Abington, Pennsylvania 19001
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Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Abington, PA
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Albany, New York 12208
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Albany, NY
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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Anderson, SC
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Camden, NJ
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1653 W. Congress Parkway
Chicago, Illinois 60612
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2500 Metrohealth Dr
Cleveland, Ohio 44109
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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3535 Olentangy River Rd
Columbus, Ohio 43214
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600 East Blvd
Elkhart, Indiana 46515
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Grand Rapids, Michigan 49546
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Greenville, North Carolina 27858
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80 Seymour St
Hartford, Connecticut 6102
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Hinsdale, IL
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Independence, Missouri 64057
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545 Barnhill Dr
Indianapolis, Indiana 46201
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2001 W 86th St
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Saint Vincent Hospital and Health Services At St.Vincent Indianapolis, everything we do begins with a...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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2301 Holmes
Kansas City, Missouri 64108
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3500 S. Lafountain Street
Kokomo, Indiana 46902
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Community Howard Regional Health Selecting quality health care services for yourself, a relative or friend...
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La Porte, Indiana 46350
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100 Grand St
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1275 York Ave
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940 NE 13th St
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Philadelphia, Pennsylvania 19111
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Providence, Rhode Island 02905
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Roanoke, Virginia 24016
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Saint Joseph, Michigan 49085
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3635 Vista at Grand Ave.
Saint Louis, Missouri 63110
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660 S Euclid Ave
Saint Louis, Missouri 63110
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Savannah, Georgia 31404
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211 North Eddy St.
South Bend, Indiana 46617
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South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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615 N Michigan Street
South Bend, Indiana 46601
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Northern Indiana Cancer Research Consortium The Northern Indiana Cancer Research Consortium (NICRC) is comprised of...
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1235 E Cherokee St
Springfield, Missouri 65804
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1235 E Cherokee St
Springfield, Missouri 65804
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Mercy Hospital Springfield We're continuing a tradition of healing more than 120 years old. Mercy...
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12697 E 51st Street South
Tulsa, Oklahoma 74146
918-505-3200
Tulsa Cancer Institute, Pllc Now under the new name of Tulsa Cancer Institute, our specialists...
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110 Irving St NW
Washington, District of Columbia 20010
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Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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