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CCI-779 in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: National Cancer Institute of Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072176
  Purpose

RATIONALE: Drugs used in chemotherapy, such as CCI-779, use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with metastatic or locally advanced recurrent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: temsirolimus
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: CCI 779
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of CCI-779 in Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response measured by RECIST criteria after accrual of 30 evaluable patients in stratum I and 25 evaluable patients in stratum II [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity assessed by CTCAE v3.0 criteria [ Designated as safety issue: Yes ]
  • Correlative studies on archival tissue [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2004
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072176

Locations
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
Investigator: Laurie Elit, MD Margaret and Charles Juravinski Cancer Centre
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
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.

Study ID Numbers: CDR0000335543, CAN-NCIC-IND160
Study First Received: November 4, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00072176  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma
endometrial papillary carcinoma
endometrial clear cell carcinoma
endometrial adenosquamous cell carcinoma
endometrial adenocarcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Study placed in the following topic categories:
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Recurrence
Carcinoma
Genital Diseases, Female
Endometrial Neoplasms
Adenocarcinoma, Clear Cell
Carcinoma, Papillary
Uterine Neoplasms
Endometrial cancer
Adenocarcinoma
Carcinoma, Adenosquamous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009