Canadian Cancer Trials Group - Tumour Bank
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I148 Details
Status: Closed 
Activation Date: 2002JAN10
Closing Date: 2004MAR16
Phase: II 

Description: A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium 

Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Patients may have had up to one prior hormonal treatment (adjuvant or metastatic). No prior chemotherapy permitted. No prior EGFR targeting therapy permitted. 

Objective: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced/metastatic carcinoma of the endometrium. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR expression from primary tumour in these patients. To explore patterns of change in markers of EGFR activation in patients that have biopsies (additional investigations). 

Lay Description: The main purpose of this study is to find out what effects an experimental drug called OSI-774 has on patients with endometrial cancer, and to find out the side effects (good or bad) the drug causes. As well, researchers will look at tumour tissue samples to find out what effects the drug has on individual cancer cells. 

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Inventory
Hide Tissue Samples
Disease Site Trial Code Patients Accrued Patients - Blocks Patients - Slides Patients - Blocks and/or Slides
IND I148 34 16 29 29
Hide TMA Samples
(Core size is 0.6 mm)
Disease Site Trial Code Patients Accrued TMA Blocks Patients on TMA Blocks
IND I148 34 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 I148 34 0 0 0 0 0 0 0 0