Phase I study of irinotecan and raltitrexed in patients with advanced astrointestinal tract adenocarcinoma
2000

Study of Irinotecan and Raltitrexed for Advanced Cancer

Sample size: 33 publication Evidence: moderate

Author Information

Author(s): Ford H E R, Cunningham D, Ross P J, Rao S, Aherne G W, Benepal T S, Price T, Massey A, Vernillet L

Primary Institution: Royal Marsden NHS Trust

Hypothesis

What are the dose-limiting toxicities and maximum tolerated dose of irinotecan and raltitrexed in patients with advanced gastrointestinal adenocarcinoma?

Conclusion

The combination of irinotecan and raltitrexed is active with manageable toxicity.

Supporting Evidence

  • 33 patients with pretreated gastrointestinal adenocarcinoma participated in the study.
  • Only one patient at lower dose levels experienced dose-limiting toxicity.
  • At the maximum tolerated dose, 5 out of 12 patients experienced dose-limiting toxicity.
  • Pharmacokinetic data showed no measurable drug interaction.
  • 20% of patients had objective responses to the drug combination.

Takeaway

Doctors tested two cancer drugs together to see how much they could give without making patients too sick, and they found a safe amount that works.

Methodology

This was an open label dose-escalation study with 33 patients receiving sequential short infusions of irinotecan and raltitrexed every 3 weeks.

Participant Demographics

Patients had pretreated gastrointestinal adenocarcinoma, with 31 colorectal and 2 oesophagogastric cases.

Digital Object Identifier (DOI)

10.1054/bjoc.2000.1192

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication