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Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma
M M Zalupski1, P A Philip, P LoRusso
1Karmanos Cancer Institute, Department of Medicine, Wayne State University, Detroit, MI 48201, USA.
Purpose:
Pyrazoloacridine (PZA) is an acridine derivative selected for clinical development because of broad preclinical antitumor activity and solid tumor selectivity. Phase I evaluations with PZA have demonstrated predictable toxicity and suggested clinical efficacy. A phase II trial in patients with previously untreated advanced colorectal cancer was conducted.
Methods:
PZA was administered at a dose of 750 mg/m2 intravenously over 3 h every 21 days to patients who received a total of 31 courses of PZA.
Results:
In 15 patients evaluable for response, no responses were observed (0% response rate, 95% confidence interval 0-22%). Toxicity to PZA consisted of myelosuppression and neurotoxicity that was treatment-limiting in several instances.
Conclusion:
PZA at this dose and schedule of administration is inactive in patients with colorectal cancer.