Phase II study of the combination of the novel bioreductive agent, tirapazamine, with cisplatin in patients with advanced non-small-cell lung cancer Journal Article
| Authors: | Miller, V. A.; Ng, K. K.; Grant, S. C.; Kindler, H.; Pizzo, B.; Heelan, R. T.; von Roemeling, R.; Kris, M. G. |
| Article Title: | Phase II study of the combination of the novel bioreductive agent, tirapazamine, with cisplatin in patients with advanced non-small-cell lung cancer |
| Abstract: | Purpose: Tirapazamine is a bioreductive compound synergistic with cisplatin in preclinical testing. This phase II study was conducted to evaluate the efficacy and toxicity of tirapazamine with cisplatin in patients with advanced non-small-cell lung cancer. Patients and methods: Twenty patients with unresectable stage III-B and IV non-small-cell lung cancer who had not received prior chemotherapy were given tirapazamine (390 mg/m2) intravenously (i.v.) over two hours followed one hour later by cisplatin (75 mg/m2) i.v. over one hour every 21 days. Results: Five of 20 patients (25%) had major objective responses (95% confidence interval, 11%-50%). Median duration of response was eight months with a one-year survival of 40%. Toxicities included temporary hearing loss (25%), muscle cramping, diarrhea, skin rash and nausea/vomiting. No grade 3 or 4 hematologic or renal toxicity was observed. Conclusions: The combination of tirapazamine plus cisplatin appears to be safe and active in the treatment of advanced non-small lung cancer without a substantial increase in toxicity compared to cisplatin alone. A phase III randomized study comparing the combination to cisplatin alone has completed accrual. Further evaluation of tirapazamine with other active agents and in multi-modality therapy is warranted. |
| Keywords: | clinical article; treatment outcome; clinical trial; cisplatin; advanced cancer; cancer combination chemotherapy; diarrhea; dose response; chemotherapy; neurotoxicity; phase 2 clinical trial; lung non small cell cancer; nausea; vomiting; antineoplastic combined chemotherapy protocols; carcinoma, non-small-cell lung; lung neoplasms; rash; drug synergism; multicenter study; inoperable cancer; hearing loss; intravenous drug administration; non-small-cell lung cancer; muscle cramp; tirapazamine; ototoxicity; triazines; humans; human; priority journal; article; sr 4233; win 59075 |
| Journal Title: | Annals of Oncology |
| Volume: | 8 |
| Issue: | 12 |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Date Published: | 1997-12-01 |
| Start Page: | 1269 |
| End Page: | 1271 |
| Language: | English |
| DOI: | 10.1023/a:1008219125746 |
| PUBMED: | 9496394 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 17 March 2017 -- Source: Scopus |
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