A Phase II Study of CCI-779 in Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic or locally advanced recurrent endometrial
carcinoma, including 1 of the following types:

- Adenocarcinoma

- Papillary serous

- Papillary

- Villoglandular

- Mucinous

- Clear cell

- Endometrioid

- Adenosquamous

- At least 1 unidimensionally measurable site of disease* meeting at least 1 of the
following criteria:

- At least 20 mm by x-ray or physical exam

- At least 10 mm by spiral CT scan

- At least 20 mm by non-spiral CT scan NOTE: *Bone metastases are considered
nonmeasurable

- Not curable by standard therapy

- Available tissue from the primary tumor

- No uterine sarcomas (leiomyosarcoma), mixed mullerian tumors, or adenosarcomas

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 50 mL/min

Cardiovascular

- No myocardial infarction within the past 6 months

- No serious cardiovascular illness

- No congestive heart failure

- No unstable angina

- No active cardiomyopathy

- No unstable ventricular arrhythmia

- No uncontrolled hypertension

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Fasting cholesterol no greater than 9.0 mmol/L

- Fasting triglycerides no greater than 4.56 mmol/L

- No other prior or concurrent malignancy except adequately treated nonmelanoma skin
cancer, curatively treated carcinoma in situ of the cervix, or other curatively
treated solid tumors with no evidence of disease for at least 5 years

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to CCI-779

- No history of significant neurologic or psychiatric disorder that would preclude the
ability to give consent or limit compliance with study requirements

- No serious illness or medical condition that would preclude management of the patient
according to study guidelines

- No active uncontrolled infection

- No active peptic ulcer disease

- No medical condition that would be aggravated by study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent prophylactic hematopoietic colony-stimulating factor therapy

Chemotherapy

- No prior chemotherapy (for patients in stratum I)

- Must have had one prior chemotherapy regimen for metastatic disease (for patients in
stratum II)

- At least 4 weeks since prior chemotherapy

- No prior treatment with mTOR inhibitors

Endocrine therapy

- At least 1 week since prior hormonal therapy

- No more than 1 prior hormonal treatment (progestational or aromatase inhibitor) as
either adjuvant therapy or for treatment of metastatic disease (for patients in
stratum I)

Radiotherapy

- At least 28 days since prior radiotherapy and recovered

- No concurrent radiotherapy to the sole site of measurable disease before assessment
of response

Surgery

- At least 21 days since prior major surgery and recovered

Other

- No other concurrent investigational therapy

- No other concurrent anticancer therapy