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Ribonucleotide reductase (RNR) is an enzyme involved in the  de novo  synthesis of deoxyribonucleotides, which are critical for DNA replication and DNA repair. Triapine is a small-molecule RNR inhibitor. A phase I trial studied the safety of triapine in combination with cisplatin–paclitaxel in patients with advanced stage or metastatic solid tumor cancers in an effort to capitalize on disrupted DNA damage repair. A total of 13 patients with various previously treated cancers were given a 96-h continuous intravenous (i.v.) infusion of triapine (40–120 mg/m 2 ) on day 1, and then 3-h i.v. paclitaxel (80 mg/m 2 ) followed by 1-h i.v. cisplatin (50–75 mg/m 2 ) on day 3. This combination regimen was repeated every 21 days. The maximum tolerated dose (MTD) for each agent was identified to be triapine (80 mg/m 2 ), cisplatin (50 mg/m 2 ), and paclitaxel (80 mg/m 2 ). Common grade 3 or 4 toxicities included reversible anemia, leukopenia, thrombocytopenia, or electrolyte abnormalities. The combination regimen of triapine–cisplatin–paclitaxel resulted in no objective responses; however, five (83%) of six patients treated at the MTD had stable disease between 1 and 8 months duration. This phase I study showed that the combination regimen of triapine–cisplatin–paclitaxel was safe and provides a rational basis for a follow-up phase II trial to evaluate efficacy and progression-free survival in women with metastatic or recurrent uterine cervix cancer.

Phase I Trial of Triapine–Cisplatin–Paclitaxel Chemotherapy for Advanced Stage or Metastatic Solid Tumor Cancers