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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | NCIC Clinical Trials Group |
| 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 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Enrollment: | 62 |
| Study Start Date: | March 2004 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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
Contacts and Locations| Canada, Alberta | |
| 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 | |
| Canada, Ontario | |
| 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 | |
| Canada, Quebec | |
| 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 |
More Information
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00072176 History of Changes |
| Other Study ID Numbers: | I160, CAN-NCIC-IND160, CDR0000335543 |
| Study First Received: | November 4, 2003 |
| Last Updated: | September 27, 2011 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
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 Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue |
Endometrial Stromal Tumors Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |