Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

CCI-779 in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CAN-NCIC-IND160 NCT00072176, NCIC-160, IND160

Objectives

Primary

1. 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.
2. Determine the adverse events, time to progression, and response duration in patients treated with this drug.

Secondary

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

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

Toxicity assessed by CTCAE v3.0 criteria
Correlative studies on archival tissue

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.

Oza AM, Elit L, Provencher D, et al.: A phase II study of temsirolimus (CCI-779) in patients with metastatic and/or locally advanced recurrent endometrial cancer previously treated with chemotherapy: NCIC CTG IND 160b. [Abstract] J Clin Oncol 26 (Suppl 15): A-5516, 2008.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Amit Oza, MD, Protocol chair		Ph: 416-946-2818
Laurie Elit, MD, Protocol co-chair		Ph: 905-389-5688 ext. 64908 Email: laurie.elit@hrcc.on.ca

Registry Information
Official Title		A Phase II Study of CCI-779 in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer
Trial Start Date		2004-03-03
Registered in ClinicalTrials.gov		NCT00072176
Date Submitted to PDQ		2003-09-18
Information Last Verified		2008-05-20
NCI Grant/Contract Number		CM17107

Back to Top