CCI-779 in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of CCI-779 in Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer|
- Objective response measured by RECIST criteria after accrual of 30 evaluable patients in stratum I and 25 evaluable patients in stratum II [ Time Frame: 5 years ] [ Designated as safety issue: No ]Final analysis performed 2009May27
- Toxicity assessed by CTCAE v3.0 criteria [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Final analysis 2009May27
- Correlative studies on archival tissue [ Time Frame: 7 years ] [ Designated as safety issue: No ]JCO publication accepted 2011Apr20
|Study Start Date:||March 2004|
|Study Completion Date:||August 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
25 mg of CCI-779 administered over 30 minutes IV weekly continuously
- 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.
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, Nova Scotia|
|QEII Health Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|CHUM - Hopital Notre-Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|CHUQ-Pavillon Hotel-Dieu de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Study Chair:||Amit M. Oza, MD||Princess Margaret Hospital, Canada|
|Study Chair:||Laurie Elit, MD||Margaret and Charles Juravinski Cancer Centre|