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

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

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Trial Information

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



- Determine the efficacy of CCI-779, in terms of response rate and duration of stable
disease, in patients with metastatic or locally advanced recurrent endometrial cancer.

- Determine the adverse events, time to progression, and response duration in patients
treated with this drug.


- Correlate objective tumor response with PTEN expression and other molecular measures in
the tumor tissue of these patients obtained at diagnosis (primary tumor).

OUTLINE: This is a nonrandomized, multicenter study. Patients are stratified according to
prior chemotherapy (no [stratum I] vs yes [stratum II]).

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients with stable disease may receive additional courses of treatment at the
discretion of the investigator.

After completion of study treatment, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Inclusion Criteria


- 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

- Not curable by standard therapy

- Available tissue from the primary tumor

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

- No known brain metastases



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks


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

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


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

- AST and ALT no greater than 2.5 times ULN


- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 50 mL/min


- 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


- 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


Biologic therapy

- No concurrent prophylactic hematopoietic colony-stimulating factor therapy


- 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)


- At least 28 days since prior radiotherapy and recovered

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


- At least 21 days since prior major surgery and recovered


- No other concurrent investigational therapy

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response measured by RECIST criteria after accrual of 30 evaluable patients in stratum I and 25 evaluable patients in stratum II

Outcome Description:

Final analysis performed 2009May27

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Amit M. Oza, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

August 2009

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • endometrial papillary carcinoma
  • endometrial clear cell carcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial adenocarcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma