A phase 1 dose-escalation study on the safety, tolerability and activity of liposomal curcumin (Lipocurc™) in patients with locally advanced or metastatic cancer
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, o...
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| Vydané v: | Cancer chemotherapy and pharmacology Ročník 82; číslo 4; s. 695 - 706 |
|---|---|
| Hlavní autori: | , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
| Vydavateľské údaje: |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.10.2018
Springer Nature B.V |
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| ISSN: | 0344-5704, 1432-0843, 1432-0843 |
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| 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
2
over 8 h and the dose increased to 300 mg/m
2
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
2
over 8 h. Of six patients receiving 300 mg/m
2
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
2
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. |
|---|---|
| AbstractList | 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.PURPOSEThis 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.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/m2 over 8 h and the dose increased to 300 mg/m2 over 6 h.METHODSIn 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/m2 over 8 h and the dose increased to 300 mg/m2 over 6 h.32 patients were treated. No dose-limiting toxicity was observed in 26 patients at doses between 100 and 300 mg/m2 over 8 h. Of six patients receiving 300 mg/m2 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.RESULTS32 patients were treated. No dose-limiting toxicity was observed in 26 patients at doses between 100 and 300 mg/m2 over 8 h. Of six patients receiving 300 mg/m2 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.300 mg/m2 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.CONCLUSION300 mg/m2 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. 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. 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. 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. 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. 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 2 over 8 h and the dose increased to 300 mg/m 2 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 2 over 8 h. Of six patients receiving 300 mg/m 2 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 2 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. PurposeThis 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.MethodsIn 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/m2 over 8 h and the dose increased to 300 mg/m2 over 6 h.Results32 patients were treated. No dose-limiting toxicity was observed in 26 patients at doses between 100 and 300 mg/m2 over 8 h. Of six patients receiving 300 mg/m2 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.Conclusion300 mg/m2 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. |
| Author | Bolger, Gordon T. Schönlieb, Charlotte Radl, Bianca Weiss, Lukas Sordillo, Peter P. Greil, Richard Magnes, Teresa Greil-Ressler, Sigrun Vcelar, Brigitta |
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| Keywords | Hemolysis Prostate carcinoma Curcumin Phase I cancer trials Colon carcinoma Lipocurc |
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This study was conducted to investigate the safety and tolerability of increasing doses of liposomal curcumin in patients with metastatic cancer.... This study was conducted to investigate the safety and tolerability of increasing doses of liposomal curcumin in patients with metastatic cancer.... PurposeThis study was conducted to investigate the safety and tolerability of increasing doses of liposomal curcumin in patients with metastatic cancer.... |
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| SubjectTerms | Adult Aged Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - pharmacokinetics Antitumor agents Cancer Cancer Research Clinical trials Colonic Neoplasms - drug therapy Colonic Neoplasms - pathology Colorectal cancer Curcumin Curcumin - administration & dosage Curcumin - adverse effects Curcumin - pharmacokinetics Dose-Response Relationship, Drug Drug Monitoring - methods Drug Tolerance Drug-Related Side Effects and Adverse Reactions - blood Drug-Related Side Effects and Adverse Reactions - diagnosis Drug-Related Side Effects and Adverse Reactions - etiology Female Hemoglobin Hemoglobins - analysis Hemolysis Hemolysis - drug effects Humans Intravenous administration Male Medicine Medicine & Public Health Metastases Metastasis Middle Aged Neoplasm Invasiveness Neoplasm Metastasis - drug therapy Neoplasm Metastasis - pathology Neoplasm Staging Oncology Original Original Article Pharmacokinetics Pharmacology/Toxicology Prostate cancer Prostatic Neoplasms - drug therapy Prostatic Neoplasms - pathology Toxicity Treatment Outcome Tumor markers Tumors |
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| Title | A phase 1 dose-escalation study on the safety, tolerability and activity of liposomal curcumin (Lipocurc™) in patients with locally advanced or metastatic cancer |
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