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A Randomized Phase II Trial of Temsirolimus (NCI-Supplied Agent, NSC # 683864, IND # 61010) or the Combination of Hormonal Therapy Plus Temsirolimus in Women With Advanced, Persistent, or Recurrent Endometrial Carcinoma


Phase 2
N/A
N/A
Open (Enrolling)
Female
Recurrent Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma

Thank you

Trial Information

A Randomized Phase II Trial of Temsirolimus (NCI-Supplied Agent, NSC # 683864, IND # 61010) or the Combination of Hormonal Therapy Plus Temsirolimus in Women With Advanced, Persistent, or Recurrent Endometrial Carcinoma


PRIMARY OBJECTIVES:

I. To determine the response rate in patients with advanced, persistent, or recurrent
endometrial carcinoma treated with temsirolimus with or without hormonal therapy comprising
megestrol acetate and tamoxifen citrate.

II. To determine the time to progression and number of patients remaining on study therapy
at 24 weeks.

SECONDARY OBJECTIVE:

III. To describe the toxicities of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment
for endometrial carcinoma (adjuvant chemotherapy or chemoradiotherapy at the time of initial
diagnosis or for a pelvic recurrence vs no adjuvant chemotherapy or chemoradiotherapy at the
time of initial diagnosis or for a pelvic recurrence). Patients are randomized to 1 of 2
treatment arms (arm II closed to accrual as of 12/21/09).

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 12/21/09): Patients receive temsirolimus as in arm I.
Patients also receive oral megestrol acetate twice daily for 3 weeks alternating with oral
tamoxifen citrate twice daily 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 periodically for 1 year.


Inclusion Criteria:



- Histologically* confirmed endometrial carcinoma

- NOTE: *Histologic documentation of recurrence is not required

- Advanced (FIGO stage III or IV), persistent, or recurrent disease that cannot be
cured by surgery or radiotherapy

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques (e.g., palpation, plain x-ray, CT scan, and MRI) or ≥ 10 mm
by spiral CT scan

- Must have at least one "target lesion" to be used to assess response, as defined by
RECIST criteria

- Tumors within a previouslyirradiated field will be designated as "non-target"
lesions unless progression isdocumented

- No sarcoma, carcinosarcoma, or leiomyosarcoma of the uterine corpus

- GOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mcL

- Platelet count ≥ 100,000/mcL

- Total bilirubin normal

- AST ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver
metastases)

- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver
metastases)

- Creatinine ≤ 1.5 times ULN

- Cholesterol ≤ 350 mg/dL (fasting)

- Triglycerides ≤ 400 mg/dL (fasting)

- Albumin ≥ 3.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- Able to take oral medication

- No known congestive heart failure

- No baseline requirement for oxygen

- No history of unprovoked deep vein thrombosis or pulmonary embolism, unless patient
is maintained on anticoagulation for the duration of the study

- No concurrent serious illness that, in the opinion of the treating physician, would
place the patient at unreasonable risk from study therapy

- No other invasive malignancy within the past 5 years, except non-melanoma skin cancer

- At least 4 weeks since prior major surgery (e.g, hysterectomy or resection of a lung
nodule)

- At least 4 weeks since minor surgery (e.g., port-a-cath placement)

- No more than 1 prior chemotherapy regimen (including chemoradiotherapy)

- No prior chemotherapy for stage IV disease, except in the case where the patient
was without evidence of disease at the completion of chemotherapy and had at
least 6 months of progression-free survival since the completion of chemotherapy

- Prior chemoradiotherapy for a pelvic recurrence is allowed

- Prior chemotherapy in the adjuvant setting for stage I, II, or III disease is
allowed

- No prior chemotherapy for metastatic or recurrent disease except as noted above

- No prior hormonal or biologic therapy for endometrial carcinoma

- No prior cancer treatment that would contraindicate study therapy

- No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin,
carbamazepine, or phenobarbital) or any other CYP3A4 inducer (e.g., rifampin or St.
John's wort)

- No concurrent maintenance corticosteroids, except for short-term use (i.e., < 5 days)

- No concurrent prophylactic granulocyte colony-stimulating factors

- Concurrent granulocyte colony-stimulating factors for neutropenic fever allowed

- No concurrent oral contraceptives

- No other concurrent investigational agents

- No other concurrent anticancer therapies

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of complete and partial clinical response, measured using GOG RECIST Criteria

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Gini Fleming

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-01085

NCT ID:

NCT00729586

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Recurrent Endometrial Carcinoma
  • Stage III Endometrial Carcinoma
  • Stage IV Endometrial Carcinoma
  • Carcinoma
  • Adenoma
  • Endometrial Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Abington Memorial HospitalAbington, Pennsylvania  19001
Hurley Medical CenterFlint, Michigan  48503
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Rush University Medical CenterChicago, Illinois  60612-3824
North Shore University HospitalManhasset, New York  11030
Hartford HospitalHartford, Connecticut  06102-5037
Franklin Square Hospital CenterBaltimore, Maryland  21237
William Beaumont HospitalRoyal Oak, Michigan  48073
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
MetroHealth Medical CenterCleveland, Ohio  44109
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Munson Medical CenterTraverse City, Michigan  49684
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Parkland Memorial HospitalDallas, Texas  75235
Beebe Medical CenterLewes, Delaware  19958
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Zale Lipshy University HospitalDallas, Texas  75235-7786
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Metro Health HospitalGrand Rapids, Michigan  49506
University of VirginiaCharlottesville, Virginia  22908
University of North CarolinaChapel Hill, North Carolina  27599
Independence Regional Health CenterIndependence, Missouri  64050
University of California at San DiegoLa Jolla, California  92093
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
Providence Portland Medical CenterPortland, Oregon  97213-3635
Indiana University Medical CenterIndianapolis, Indiana  46202
University of Texas Southwestern Medical CenterDallas, Texas  
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Memorial Health University Medical CenterSavannah, Georgia  31404
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
University of CincinnatiCincinnati, Ohio  45267-0502
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
John B Amos Cancer CenterColumbus, Georgia  31904
Saint Vincent Hospital and Health ServicesIndianapolis, Indiana  46260
Radiation Oncology Practice Corporation SouthwestOverland Park, Kansas  66210
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Green Bay Oncology - EscanabaEscanaba, Michigan  49431
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Radiation Oncology Practice Corporation - NorthKansas City, Missouri  64154
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Radiation Oncology Practice Corporation SouthKansas City, Missouri  64114
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Truman Medical CenterKansas City, Missouri  64108
Saint John's HospitalSpringfield, Missouri  65804
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Legacy Good Samaritan Hospital and Medical CenterPortland, Oregon  97210
Northwest Cancer Specialists-Rose Quarter Cancer CenterPortland, Oregon  97227
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Women and Infants HospitalProvidence, Rhode Island  02905
Colorado Gynecologic Oncology GroupAurora, Colorado  80010
Stony Brook University Medical CenterStony Brook, New York  11794
University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado  80045
Saint Paul HospitalDallas, Texas  75235
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Gynecologic Oncology of West Michigan PLLCGrand Rapids, Michigan  49546
Monter Cancer CenterLake Success, New York  11042
Black Hills Obstetrics and GynecologyRapid City, South Dakota  57701
Carilion Clinic Gynecological OncologyRoanoke, Virginia  24016
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
Southwest Gynecologic Oncology Associates IncAlbuquerque, New Mexico  87106
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Saint Luke's South HospitalOverland Park, Kansas  66213
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Saint Joseph Oncology IncSaint Joseph, Missouri  64507
Gundersen LutheranLa Crosse, Wisconsin  54601
Stanford University Hospitals and ClinicsStanford, California  94305
Sudarshan K Sharma MD Limted-Gynecologic OncologyHinsdale, Illinois  60521
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Bronson Battle CreekBattle Creek, Michigan  49017
Women's Cancer Care Associates LLCAlbany, New York  12208
Providence Cancer Center -The PlazaPortland, Oregon  97213