Status: Closed
Activation Date: 2004JAN14
Closing Date: 2007JUN15
Phase: II
Description: A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer
Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of CCI-779 activation. Group A patients may have had up to one prior hormonal treatment (adjuvant or metastatic) with no prior chemotherapy permitted. Group B patients may have had an unlimited number of prior hormonal treatments (adjuvant or metastatic) and must have had one cycle of cytotoxic chemotherapy.
Objective: To assess the efficacy (response rate and duration of stable disease) of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour). To explore the relatinoship between objective tumour response with other molecular measures in diagnostic tumour tissue.
Participation: Limited to invited centres only.
Lay Description: The main purpose of this study is to find out what effects an experimental drug called CCI-779 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 (from a sample of endometrial cancer that was removed at the time of the initial diagnosis) to find out what effects CCI-779 has on individual cancer cells. Patients who meet all of the eligibility criteria will be given CCI-779 by needle into a vein over 30 minutes once a week. Treatment will be repeated every 4 weeks.
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Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
IND | I160 | 62 | 33 | 54 | 56 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
IND | I160 | 62 | 0 | 0 |
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 | I160 | 62 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |