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Therapeutic Areas: Oncology
Disease Category: Endometrial Cancer

Trial Information

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

RATIONALE: 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 and tamoxifen 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 and tamoxifen in treating endometrial cancer.

PURPOSE: This randomized phase II trial is studying temsirolimus to see how well it works with or without megestrol and tamoxifen in treating patients with advanced, persistent, or recurrent endometrial cancer. Inclusion criteria

DISEASE CHARACTERISTICS:

• Histologically* confirmed endometrial carcinoma
  • Advanced (FIGO stage III or IV), persistent, or recurrent disease that cannot be cured by surgery or radiotherapy
• NOTE: *Histologic documentation of recurrence is not required
• 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 previously irradiated field will be designated as "non-target" lesions unless progression is documented
• No sarcoma, carcinosarcoma, or leiomyosarcoma of the uterine corpus

PATIENT CHARACTERISTICS:

• 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

Exclusion criteria

PRIOR CONCURRENT THERAPY:

• 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

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education at Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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