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Phase I Trial of Arginine Deprivation Therapy with ADI-PEG 20 Plus Docetaxel in Patients with Advanced Malignant Solid Tumors. | LitMetric

AI Article Synopsis

  • This phase I study explored the safety and tolerability of pegylated arginine deiminase (ADI-PEG 20) combined with docetaxel in patients with advanced solid tumors.
  • The study involved 18 patients who received varying doses of ADI-PEG 20 alongside docetaxel, tracking safety, toxicity, and tumor responses, with a focus on managing circulating arginine levels.
  • Overall, while there were some toxicities, the combination showed promising signs of clinical activity and further studies are planned for specific cancer types at a recommended dose of 36 mg/m².

Article Abstract

Purpose: This phase I study examined the toxicity and tolerability of pegylated arginine deiminase (ADI-PEG 20) in combination with docetaxel in patients with advanced solid malignancies.

Experimental Design: Eligible patients had histologically proven advanced solid malignancies, with any number of prior therapies, Zubrod performance status 0-2, and adequate organ function. Patients received ADI-PEG 20 weekly intramuscular injection ranging from 4.5 to 36 mg/m(2) and up to 10 doses of docetaxel (75 mg/m(2)) every 3 weeks. Primary endpoints were safety, toxicity, and a recommended phase II dose. Circulating arginine levels were measured before each cycle. Tumor response was measured as a secondary endpoint every 6 weeks on study.

Results: Eighteen patients received a total of 116 cycles of therapy through four dose levels of ADI-PEG 20. A single dose-limiting toxicity (grade 3 urticarial rash) was observed at the 1st dose level, with no additional dose-limiting toxicities observed. Hematologic toxicities were common with 14 patients experiencing at least one grade 3 to 4 leukopenia. Fatigue was the most prevalent toxicity reported by 16 patients. Arginine was variably suppressed with 10 patients achieving at least a 50% reduction in baseline values. In 14 patients with evaluable disease, four partial responses (including 2 patients with PSA response) were documented, and 7 patients had stable disease.

Conclusions: ADI-PEG 20 demonstrated reasonable toxicity in combination with docetaxel. Promising clinical activity was noted, and expansion cohorts are now accruing for both castrate-resistant prostate cancer and non-small cell lung cancer at a recommended phase II dose of 36 mg/m(2).

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4452427PMC
http://dx.doi.org/10.1158/1078-0432.CCR-14-2610DOI Listing

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