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Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00072176 |
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 |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or locally advanced recurrent endometrial carcinoma, including 1 of the following types:
Adenocarcinoma
At least 1 unidimensionally measurable site of disease* meeting at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Must have had one prior chemotherapy regimen for metastatic disease (for patients in stratum II)
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study Chair: | Amit M. Oza, MD | Princess Margaret Hospital, Canada |
Investigator: | Laurie Elit, MD | Margaret and Charles Juravinski Cancer Centre |
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 |
recurrent endometrial carcinoma endometrial papillary carcinoma endometrial clear cell carcinoma endometrial adenosquamous cell carcinoma |
endometrial adenocarcinoma stage III endometrial carcinoma stage IV endometrial carcinoma |
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 |
Neoplasms Neoplasms by Site |