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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
Open (Enrolling)
Recurrent Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma

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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


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.


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

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

- 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

- 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

- 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:


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:


Principal Investigator

Gini Fleming

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

Related Keywords:

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



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