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Phase I study of tricyclic nucleoside phosphate using a five-day continuous infusion schedule
Cancer Research
|August 1, 1984
Summary
This Phase I trial evaluated tricyclic nucleoside phosphate in advanced cancers. The recommended dose for Phase II studies is 20 mg/sq m/day for 5 days every 6 weeks, balancing efficacy and toxicity.
Area of Science:
- Pharmacology
- Oncology
- Clinical Trials
Background:
- Tricyclic nucleoside phosphate (NSC 280594) is an investigational agent for cancer treatment.
- Phase I trials are crucial for determining safe and effective dosing regimens.
Purpose of the Study:
- To evaluate the safety and tolerability of tricyclic nucleoside phosphate.
- To identify dose-limiting toxicities and establish a recommended dose for Phase II trials.
Main Methods:
- A 5-day continuous infusion schedule was used.
- Dose escalation from 10 to 40 mg/sq m/day.
- Thirty-seven patients with advanced cancer were enrolled, with 33 evaluable for toxicity and response.
Main Results:
- Major toxicities included hyperglycemia, hepatotoxicity, and thrombocytopenia.
- Dose adjustments were made due to cumulative toxicity, extending intervals to 6 weeks.
- Observed antitumor activity included partial responses and disease stabilization in various advanced cancers.
Conclusions:
- The recommended dose for Phase II studies is 20 mg/sq m/day for 5 days every 6 weeks.
- Careful patient selection is advised due to potential severe toxicities in specific patient groups.