The Methodist Hospital The Methodist Hosp Rese

Houston, United States

The Methodist Hospital The Methodist Hosp Rese

Houston, United States
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PubMed | The Methodist Hospital The Methodist Hosp Rese
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

4784 Background: Doxorubicin formulation with improved tolerance would increase the drugs therapeutic ratio and enhance the efficacy. Anthracyclines demonstrates similar toxicity. Epirubicin has an advantage that a patient who is responding to therapy would receive a greater cumulative dose before one must discontinue the agent secondary to the potential of cardiac toxicity. Single agent activity was reported in HRPC. Docetaxel (Taxotere) represents an effective and well-tolerated agent, needing further development for HRPC. Data suggests in other solid tumors that epirubicin and taxotere is synergistic. First stage is to determine the maximum tolerated dose (MTD) of the combination ET in pts with HRPC.Eligibility included: progressive HRPC affecting bone, worsening cancer-related symptoms, increasing prostate-specific antigen (PSA) values on 2 occasions at least 2 weeks apart, castrate serum testosterone concentration of <50ng/L, disease progression after antiandrogen withdrawal, life expectancy >3 three months, Zubrod performance status of 2, and normal organ/marrow function. ET will be given by intravenous infusion over 1 hour weekly for 3 weeks on days 1, 8, and 15 over a 35-day cycle. To determine the MTD of the combination of ET, the 3+3 rule will be utilized. RECIST criteria is utilized to determine response rate.Twelve men enrolled, median age of 69 (range 53-90) years. All pts had rising PSAs as per protocol design with evidence of metastatic involvement. Baseline PSA for this group ranged from 2.6 to 408. A median of 15 weeks of therapy has been completed. Three pts have been enrolled in dose level 0, 6 pts at dose level +1, 3 pts at dose level +2. Hematologic toxicity: 5 pts grade 2 neutropenia, 1 pt grade 2 thrombocytopenia. One pt had a >50% reduction in PSA to date.Enrollment is ongoing. Further data regarding determination of the MTD, in addition to PSA response will be presented. [Figure: see text] No significant financial relationships to disclose.


PubMed | The Methodist Hospital The Methodist Hosp Rese
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

4743 Background: A subset of men post definitive local therapy (radical prostatectomy or radiation therapy) with no evidence of metastatic disease but rising prostate specific antigen (PSA) exists. Androgen ablation is palliative and effective in most men, but this population is hesitant to begin due to adverse effects. GM-CSF is a cytokine for the generation of antigen-presenting cells and priming of cellular immune responses. Thalidomide is an agent augmenting the immune system and inhibiting angiogenesis. Correlation of antitumor activity to the immune modulation and angiogenic growth factor inhibition is being investigated.Eligibility:pts who are hormone nave, failed local therapy, no evidence of radiographic involvement; evidence of progression demonstrated by at least 3 consecutive rises in PSA by intervals of at least 4 wks. (Absolute change of at least 1 ng/mL). Adequate marrow/renal/hepatic functions. GM-CSF is given at 250g/mSixteen men enrolled, median age: 71 (60-83) yrs. Ten had RP, 4 had RT, and 2 had RP/RT. All pts had rising PSAs with no evidence of metastatic disease. Baseline PSA ranged from 1.8-20.4. A median of 33 wks (1-58+) of therapy has been completed. Three pts are off study at 48, 48 and 36 wks, secondary to individual tolerance and second primary. Dose levels ranged from 4 pts at 50mg, 11 pts at 100mg, and 1 pt at 300mg. Six men are too early for PSA evaluation. Ten men had a PSA reduction of 48% or greater. The median response is 63%. Grade 1-2 toxicity included: skin rash, fatigue, peripheral neuropathy and constipation. One pt had a DVT/PE. Hematologic changes noted: leukocytosis with an associated lymphocytosis and eosinophilia.Enrollment is ongoing. Further data regarding PSA reduction, time to progression, and toxicity will be presented No significant financial relationships to disclose.

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