June Featured Clinical Trials

Chemotherapy clinical trials results

This randomized Phase 2 clinical trial is evaluating weekly administration of custirsen (OGX-011) in combination with second-line chemotherapy in patients with metastatic HRPC who were previously treated with a minimum of 2 cycles of a docetaxel-based chemotherapy regimen and progressed during or within 6 months of discontinuation of docetaxel treatment. Because custirsen has been shown to enhance chemotherapy and reverse chemotherapy resistance in preclinical in vitro and in vivo models, the aim of this study was to assess the effect of weekly custirsen treatment on tumor response and disease progression when used in combination with either mitoxantrone or re-treatment with docetaxel (as second-line chemotherapy). This was not a comparative study; the purpose of the randomization was to attempt to assure that equivalent patients were entered into the two treatment groups.

The primary objective was to assess the safety and tolerability of custirsen in combination with either mitoxantrone or docetaxel in patients with metastatic HRPC who had disease progression with first-line docetaxel chemotherapy. The secondary objective was to determine the feasibility of treatment with custirsen in combination with second line chemotherapy in these patients, assessed primarily on PSA response and pain progression but included other criteria such as disease progression and survival.

The preliminary results of this study were presented by Fred Saad, M.D., a medical oncologist at Université Montréal, at the 2008 Genitourinary Symposium of the American Society of Clinical Oncology (ASCO).

Patients were randomized to receive either mitoxantrone or docetaxel. All patients received three loading doses of custirsen (640 mg) during a nine day period immediately prior to receiving chemotherapy. Custirsen was then given weekly. Patients received treatment on a 3 week cycle until disease progression or up to 9 cycles of chemotherapy.

Forty-six (46) patients were randomized (24 to the mitoxantrone plus custirsen treatment group and 22 to the docetaxel plus custirsen treatment group). Of the 46 patients randomized, 42 received at least one cycle of custirsen and chemotherapy and are included in this analysis. Two patients never received treatment (one in each treatment group) and 2 patients received custirsen but did not receive chemotherapy (one patient in the mitoxantrone treatment group withdrew consent and one patient in the docetaxel treatment group withdrew from treatment because of rapid disease progression). Therefore, 20 patients who received docetaxel in combination with custirsen and 22 patients who received mitoxantrone in combination with custirsen were evaluable for treatment response. This was a non-comparative clinical trial and therefore the data from each treatment group are presented separately.

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