Canadian Cancer Trials Group - Tumour Bank
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Location: Home - Disease Sites - - I199
I199 Details
Status: Closed 
Activation Date: 2009DEC17
Closing Date: 2011OCT27
Phase: II 

Description: A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix. 

Eligibility: Patients with histologically or cytologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the cervix, or adenocarcinoma of the cervix. Clinically and/or radiologically documented disease. Only one prior chemotherapy regimen allowed. Patient must be > 4 weeks since chemotherapy, radiation therapy and surgery. No prior treatment with an mTOR inhibitor. Patient must have tumour tissue from their primary tumour available. 

Objective: 1.1 To assess the efficacy (objective response rate) of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.2 To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.3 To explore the relationship between expression of proteins in the mTOR pathway in archival tissue samples from patients on this trial and their objective response to therapy. 

Participation: Limited to invited centres 

Lay Description: The main purpose of this study is to find out how effective the experimental drug temsirolimus is in treating cervical cancer. In addition, this study will look at the side effects of temsirolimus when given IV weekly. Additional research will investigate tissue samples from previously removed cervical lesions. 

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Inventory
Hide Tissue Samples
Disease Site Trial Code Patients Accrued Patients - Blocks Patients - Slides Patients - Blocks and/or Slides
IND I199 38 21 36 36
Hide TMA Samples
(Core size is 0.6 mm)
Disease Site Trial Code Patients Accrued TMA Blocks Patients on TMA Blocks
IND I199 38 0 0
Hide Fluid Samples
Disease Site Trial Code Patients Accrued Patients - Whole Blood Patients - Cellular Component of Blood Patients - DNA extracted from Blood Patients - RNA extracted from Blood Patients - Plasma Patients - Serum Patients - Urine Patients - Buccal
IND I199 38 0 0 0 0 0 0 0 0