Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer



Status:Completed
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:8/29/2018
Start Date:September 2008
End Date:February 2017

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A Randomized Phase II Trial of Temsirolimus (NCI-Supplied Agent, NSC # 683864) or the Combination of Hormonal Therapy Plus Temsirolimus in Women With Advanced, Persistent, or Recurrent Endometrial Carcinoma

This randomized phase II trial studies how well temsirolimus with or without megestrol
acetate and tamoxifen citrate works in treating patients with endometrial cancer that has
spread to other places in the body and usually cannot be cured or controlled with treatment,
has returned after a period of improvement, or is persistent. Temsirolimus may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can
cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate and
tamoxifen citrate may fight endometrial cancer by blocking the use of estrogen by the tumor
cells. It is not yet known whether temsirolimus is more effective when given alone or
together with megestrol acetate and tamoxifen citrate in treating endometrial cancer.

PRIMARY OBJECTIVES:

I. To determine the response rate of patients with advanced, persistent, or recurrent
endometrial cancer when treated with each of the arms of the trial; the proposed arms are:
Arm #1 temsirolimus intravenously (IV) weekly, Arm #2 megestrol (megestrol acetate)/tamoxifen
(tamoxifen citrate) plus temsirolimus IV weekly.

II. Time to progression and number of patients remaining on study therapy at 24 weeks.

SECONDARY OBJECTIVE:

I. To describe the toxicities of each of the arms of the trial when used for patients with
advanced/metastatic endometrial cancer.

TERTIARY OBJECTIVES:

I. Explore whether immunohistochemical expression of hormone receptors (estrogen
receptor-alpha, estrogen receptor-beta, progesterone receptors-A, progesterone receptor-B and
the alternative estrogen receptor, G protein-coupled estrogen receptor [GPR]-30) or
components of the mammalian target of rapamycin (mTOR) signaling pathway (normal and mutant
phosphatase and tensin homolog [PTEN], total and phosphorylated v-akt murine thymoma viral
oncogene homolog 1 [Akt] as well as total and phosphorylated p70S6 kinase) are associated
with treatment, outcome or clinical characteristics.

II. Explore whether single nucleotide polymorphisms (SNPs) in the FK506-binding protein
12-rapamycin-associated protein 1 (FRAP1) and regulatory associated protein of mTOR (RAPTOR)
genes, mutations in phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha
(PIK3CA), PTEN and paxillin or copy number abnormalities in PTEN and paxillin are associated
with treatment, outcome or clinical characteristics.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. (Closed to accrual as of
11/22/2010)

ARM I: Patients receive temsirolimus IV over 30 minutes once weekly for 6 weeks. Courses
repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II (Closed to accrual as of 12/21/2009): Patients receive temsirolimus as in Arm I and
megestrol acetate orally (PO) twice daily (BID) for 3 weeks alternating with tamoxifen
citrate PO BID for 3 weeks. Courses repeat every 6 weeks in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 year.

Inclusion Criteria:

- Patients must have histologically confirmed advanced (International Federation of
Gynecologists and Obstetricians [FIGO] stage III or IV), persistent, or recurrent
endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy;
histologic documentation of the recurrence is not required

- All patients must have measurable disease; measurable disease is defined as at least
one lesion that can be accurately measured in at least one dimension (longest
dimension to be recorded); each lesion must be >= 20 mm when measured by conventional
techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic
resonance imaging (MRI), or >= 10 mm when measured by spiral CT

- Patients must have at least one "target lesion" to be used to assess response, as
defined by Response Evaluation Criteria In Solid Tumors (RECIST); tumors within a
previously irradiated field will be designated as "non-target" lesions unless
progression is documented

- Prior chemoradiotherapy for a pelvic recurrence is permitted; prior chemotherapy in
the adjuvant setting for stage I, II, or III disease is permitted

- Note: no prior chemotherapy in the setting of stage IV disease is permitted
unless the patient was without evidence of disease at the completion of
chemotherapy and had at least six months of progression-free survival since the
completion of chemotherapy

- Regardless of circumstances, no more than one prior chemotherapy regimen
(including chemoradiotherapy) is permitted

- Patient must be able to take p.o. medications

- Performance status must be 0-2

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
2.5 times institutional upper limit of normal v 3.0 (=< 5 times upper limit of normal
[ULN] for subjects with liver metastases)

- Alkaline phosphatase =< 2.5 times institutional upper limit of normal v 3.0 (=< 5
times ULN for subjects with liver metastases)

- Creatinine =< 1.5 times normal institutional upper limit of normal

- Cholesterol =< 350 mg/dL (fasting)

- Triglycerides =< 400 mg/dL (fasting)

- Albumin >= 3.0 mg/dL

- At least 4 weeks must have elapsed since the patient underwent any major surgery
(e.g., major: hysterectomy, resection of a lung nodule-minor: a Port-A-Cath placement)

- Patients who have met the pre-entry requirements

- Patients must have signed an approved informed consent including Health Insurance
Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

- Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4

- Patients cannot be receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g.,
phenytoin, carbamazepine, phenobarbital) nor any other cytochrome P450, family 3,
subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's wort, as
these may decrease temsirolimus levels; use of agents that potently inhibit CYP3A (and
hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not
specifically prohibited; the appropriateness of use of such agents is left to
physician discretion

- All concomitant medications must be recorded at baseline

- Patients on maintenance corticosteroids are ineligible with the exception of short
term use (fewer than 5 days)

- Patients known to have congestive heart failure; patients with baseline requirement
for oxygen; patients with serious concomitant illness that, in the opinion of the
treating physician, will place patient at unreasonable risk from therapy on this
protocol

- Patients with a history of unprovoked deep vein thrombosis (DVT) or pulmonary embolism
(PE), unless patient is maintained on anticoagulation for the duration of the trial;
while the exact definition of "provoked" is left to the treating physician, a DVT in
the setting of pelvic surgery or trauma would be considered "provoked"

- Women of child-bearing potential must have a negative pregnancy test prior to
treatment on study; breastfeeding should be discontinued if the mother is treated with
temsirolimus

- Women of child-bearing potential and men must agree to use adequate contraception
(barrier method of birth control or abstinence; oral contraceptives [also known
as "the pill"] are not acceptable) prior to study entry and for the duration of
study participation; should a woman become pregnant or suspect she is pregnant
while participating in this study, she should inform her treating physician
immediately

- Patients with a concomitant invasive malignancy or a history of other invasive
malignancies, with the exception of non-melanoma skin cancer, are excluded if there is
any evidence of other malignancy being present within the past five years; patients
are also excluded if their previous cancer treatment contraindicates this protocol
therapy

- Patients who have received hormonal therapy or biologic therapy as treatment for
endometrial carcinoma

- Patients who have received chemotherapy directed at metastatic or recurrent
endometrial carcinoma
We found this trial at
108
sites
2800 Clay Edwards Dr
Kansas City, Missouri 64116
(816) 691-2000
North Kansas City Hospital Generations of Northlanders have considered North Kansas City Hospital as their...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Albany, New York 12208
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Albuquerque, New Mexico 87106
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Ann Arbor, Michigan 48106
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Aurora, Colorado 80010
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13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
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2401 W Belvedere Ave
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265 Fremont St
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Chicago, Illinois 60612
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2500 Metrohealth Dr
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1831 Fifth Avenue
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420 S Saginaw St
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835 S Van Buren St
Green Bay, Wisconsin 54301
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80 Seymour St
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Indianapolis, Indiana 46260
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
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1721 S Stephenson Ave
Iron Mountain, Michigan 49801
(906) 776-5660
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205 NE Ave
Jackson, Michigan 49201
(517) 788-4800
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Kansas City, Missouri 64114
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Kansas City, Missouri 64114
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2301 Holmes
Kansas City, Missouri 64108
816-404-1000
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
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5400 N Oak Trafficway, Suite 101
Kansas City, Missouri 64118
(855) 603-3282
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
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La Crosse, Wisconsin
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1215 E Michigan Ave
Lansing, Michigan 48912
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3131 La Canada St # 241
Las Vegas, Nevada 89169
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100 NE St Lukes Blvd
Lee's Summit, Missouri 64086
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424 Savannah Rd
Lewes, Delaware 19958
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600 Highland Ave
Madison, Wisconsin 53792
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2300 Western Ave
Manitowoc, Wisconsin 54221
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3100 Shore Drive
Marinette, Wisconsin 54143
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Minneapolis, Minnesota 55455
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100 Grand St
New Britain, Connecticut 06050
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New Brunswick, New Jersey 08903
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270-05 76th Ave
New Hyde Park, New York 11040
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1275 York Ave
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
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855 S Main St
Oconto Falls, Wisconsin 54154
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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5721 W 119th St
Overland Park, Kansas 66209
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12300 Metcalf Ave
Overland Park, Kansas 66213
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Palo Alto, California 94304
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111 S 11th St
Philadelphia, Pennsylvania 19107
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1015 NW 22nd Ave
Portland, Oregon 97210
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
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3333 W Deyoung St
Saint Joseph, Missouri 64506
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902 N. Riverside Road Suite 200
Saint Joseph, Missouri 64507
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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Springfield, Missouri 65804
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Stony Brook, New York 11794
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323 S. 18th Avenue
Sturgeon Bay, Wisconsin 54235
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