Study of NC-6004 in Cancer Patients
Author Information
Author(s): Plummer R, Wilson R H, Calvert H, Boddy A V, Griffin M, Sludden J, Tilby M J, Eatock M, Pearson D G, Ottley C J, Matsumura Y, Kataoka K, Nishiya T
Primary Institution: Northern Institute for Cancer Research, Paul O’Gorman Building, Newcastle upon Tyne, UK
Hypothesis
NC-6004 could show lower toxicity than cisplatin and greater anti-tumour activity in phase I study.
Conclusion
The delayed and sustained release of cisplatin after i.v. administration contributes to the low toxicity of NC-6004.
Supporting Evidence
- One dose-limiting toxicity occurred at 90 mg/m², but significant cisplatin-related toxicity was generally mild.
- Stable disease was observed in seven patients.
- The maximum tolerated dose was determined to be 120 mg/m², with a recommended dose of 90 mg/m².
Takeaway
This study tested a new cancer treatment called NC-6004, which is designed to be less harmful than traditional treatments. It showed promise in keeping patients stable without causing too much harm.
Methodology
A total of 17 patients were recruited and administered NC-6004 intravenously every 3 weeks, with dose escalation from 10 mg/m² to 120 mg/m².
Limitations
The study was discontinued due to hypersensitivity reactions and renal impairment observed at higher doses.
Participant Demographics
All recruited patients were Caucasian, with a median height of 170.0 cm and a median weight of 73.0 kg.
Digital Object Identifier (DOI)
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