| General information |
| Database: | DB00228 |
| Objective: | This randomized, phase II study assessed the activity of oblimersen sodium, a Bcl2 antisense oligonucleotide, administered before docetaxel (Taxotere) to patients with castrationresistant prostate cancer. |
| Authors: | Sternberg CN, et al |
| Title: | Docetaxel plus oblimersen sodium (Bcl2 antisense oligonucleotide): an EORTC multicenter, randomizedphase II study in patients with castrationresistant prostate cancer. |
| Journal: | Ann Oncol. |
| Year: | 2009 |
| PMID: | 19297314 |
| Trial Design |
| Clinical Trial Id: | NCT00085228 |
| Agent: | oblimersen sodium
|
| Target: | Apoptosis regulator Bcl2
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | castrationresistant prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Docetaxel + oblimersen sodium |
| Study Type: | an EORTC multicenter, randomizedphase II study |
| Key Patients Feature: | Chemotherapynaive patients with prostatespecific antigen (PSA) progression and testosterone < or = 0.5 ng/ml |
| Biomarker: | PSA |
| Biomark Analysis: | NA |
| Control Group Info: | docetaxel versus docetaxel+oblimersen |
| Treatment Info: | pts received docetaxel 75 mg/m2 on day 1 or oblimersen 7 mg/kg/day continuous i.v. infusion on days 17 with docetaxel 75 mg/m2 on day 5 every 3 weeks for < or = 12 cycles. |
| Primary End Point: | confirmed PSA response (Bubley criteria) and major toxic events. |
| Secondary End Point: | NA |
| Patients Number: | 111 |
| Trial Results |
| DLT_MTD: | Oblimersen added to docetaxel was associated with an increase in the incidence of grade > or = 3 fatigue, mucositis, and thrombocytopenia. |
| Objective Response Rate: | Partial response (RECIST) was achieved in 18% and 24%, respectively. |
| Disease Control Rate: | NA |
| Median Time to Progression: | medians of 6.3 and 4.2 months without and with oblimersen, respectively. |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Major toxic events were reported in 22.8% and 40.7% of patients with docetaxel and docetaxeloblimersen, respectively. |
| Conclusions: | The primary end points of the study they were not met a rate of confirmed PSA response 30% and a major toxic event rate 45% they were not observed with docetaxeloblimersen. |