A phase I and pharmacokinetic study of intraperitoneal topotecan
2001

Study of Intraperitoneal Topotecan for Ovarian Cancer

Sample size: 15 publication Evidence: moderate

Author Information

Author(s): Hofstra L S, Bos A M E, Vries E G E de, Zee A G J van der, Beijnen J H, Rosing H, Mulder N H, Aalders J G, Willemse P H B

Primary Institution: Department of Medical, Gynaecologic Oncology, University Hospital Groningen

Hypothesis

To evaluate the feasibility and pharmacology of intraperitoneal (IP) topotecan.

Conclusion

A substantial dose of topotecan can be delivered by the IP route, achieving cytotoxic plasma levels with acceptable toxicity.

Supporting Evidence

  • Dose limiting toxicity was acute hypotension, chills, and fever at the highest dose level.
  • Mild haematological toxicity and abdominal pain were observed across all dose levels.
  • Peak plasma levels of total topotecan were reached at approximately 2.7 hours after administration.
  • The plasma AUC was correlated with the dose, indicating a strong relationship.

Takeaway

Doctors tested a new way to give a cancer medicine called topotecan directly into the belly, and it worked well without too many side effects.

Methodology

Fifteen patients with recurrent ovarian cancer were treated with escalating doses of IP topotecan for pharmacokinetic analysis.

Participant Demographics

Patients with recurrent ovarian cancer.

Statistical Information

P-Value

p<0.01

Statistical Significance

p<0.01

Digital Object Identifier (DOI)

10.1054/bjoc.2001.2161

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