A phase I study of the lipophilic thymidylate synthase inhibitor Thymitaq™ (nolatrexed dihydrochloride) given by 10-day oral administration
1999

Study of Thymitaq™ for Cancer Treatment

Sample size: 23 publication Evidence: moderate

Author Information

Author(s): Jodrell D I, Bowman A, Rye R, Byrne B, Boddy A, Rafi I, Taylor G A, Johnston A, Clendeninn N J

Primary Institution: ICRF Medical Oncology Unit, Western General Hospital

Hypothesis

Can the oral administration of Thymitaq™ (nolatrexed dihydrochloride) be safely escalated in patients?

Conclusion

The study found that while Thymitaq™ showed antiproliferative effects, nausea and vomiting were significant side effects at higher doses.

Supporting Evidence

  • Nolatrexed was administered orally at escalating doses over a 10-day period.
  • Common toxicities included nausea, vomiting, and liver function test abnormalities.
  • Three out of nine patients at 429 mg/m²/day experienced grade 3 nausea.
  • 17 out of 22 treatment courses were completed with prophylactic antiemetics.

Takeaway

Doctors tested a new cancer drug called Thymitaq™ to see how much they could give patients without making them too sick, and they found that it worked but made some people feel nauseous.

Methodology

Patients received oral Thymitaq™ every 6 hours for 10 days, with doses escalated from 80 to 572 mg/m²/day.

Limitations

The study was limited by the occurrence of dose-limiting toxicities such as nausea and vomiting.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6690146

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