AI Article Synopsis
- The study aimed to assess the safety and tolerability of increasing doses of liposomal curcumin in patients with metastatic cancer, while also exploring its anti-tumor effects and pharmacokinetics.
- Conducted in a phase I trial, 32 patients received weekly intravenous infusions of liposomal curcumin over 8 weeks, starting at 100 mg/m and increasing to 300 mg/m.
- Findings showed that 300 mg/m over 6 hours was the highest tolerated dose, with some patients experiencing minor adverse effects; no significant anti-tumor activity was observed, but two patients showed transient clinical benefits.
Article Abstract
Purpose: This study was conducted to investigate the safety and tolerability of increasing doses of liposomal curcumin in patients with metastatic cancer. Investigations of anti-tumor activity and of the pharmacokinetics of curcumin were secondary objectives.
Methods: In this phase I, single-center, open-label study in patients with metastatic tumors, liposomal curcumin was administered as a weekly intravenous infusion for 8 weeks. Dose escalation was started at 100 mg/m over 8 h and the dose increased to 300 mg/m over 6 h.
Results: 32 patients were treated. No dose-limiting toxicity was observed in 26 patients at doses between 100 and 300 mg/m over 8 h. Of six patients receiving 300 mg/m over 6 h, one patient developed hemolysis, and three other patients experienced hemoglobin decreases > 2 g/dL without signs of hemolysis. Pharmacokinetic analyses revealed stable curcumin plasma concentrations during infusion followed by rapid declines to undetectable levels after the infusion. Anti-tumor activity by RECIST V1.1 was not detected. Significant tumor marker responses and transient clinical benefit were observed in two patients.
Conclusion: 300 mg/m liposomal curcumin over 6 h was the maximum tolerated dose in these heavily pretreated patients, and is the recommended starting dose for anti-cancer trials.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132848 | PMC |
| http://dx.doi.org/10.1007/s00280-018-3654-0 | DOI Listing |
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