Status: Closed
Activation Date: 2005JUN27
Closing Date: 2006SEP29
Phase: II
Description: A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer
Eligibility: Women with histologically documented breast cancer with metastatic or locally disease refractory to standard curative therapy. Prior adjuvant chemotherapy permissible; up to one prior chemotherapy regimen for metastatic disease and no prior taxane for metastatic disease. Prior hormonal therapy permitted, prior radiation therapy permitted if radiation involved <30% functioning bone marrow and >4 weeks. HER-2 positive patients may have had prior Herceptin treatment. ECOG 0,1,2. No brain metastases, no pre-existing neuropathy >= grade 2, no therapeutic anti-coagulation.
Objective: To determine the efficacy, as measured by objective tumour response rate, of weekly OGX-011 and q 3 weekly docetaxel when given in combination to patients with advanced breast cancer. To assess the adverse events, tolerability, time to progression and overall survival in this population. To measure evidence of OGX-011 effect on serum clusterin levels.
Participation: CAKO, CALM, CAMN, CAMP, CANL, CAVA, CAVF, CAVK
Lay Description: The main purpose of this study is to find out what effects an experimental drug called OGX-011 has on patients with advanced breast cancer, when given in combination with a standard drug called docetaxel, and to find out the side effects (good or bad) these drugs cause when given together. As well, researchers will look at blood levels fo find out what effects OGX-011 has on specific markers.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I164 | 15 | 1 | 13 | 14 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I164 | 15 | 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 | I164 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |