A phase I trial of ispinesib, a kinesin spindle protein inhibitor, with docetaxel in patients with advanced solid tumours
2008

Trial of ispinesib and docetaxel in cancer patients

Sample size: 24 publication Evidence: moderate

Author Information

Author(s): Blagden S P, Molife L R, Seebaran A, Payne M, Reid A H M, Protheroe A S, Vasist L S, Williams D D, Bowen C, Kathman S J, Hodge J P, Dar M M, de Bono J S, Middleton M R

Primary Institution: Royal Marsden Hospital and Institute of Cancer Research

Hypothesis

The study aims to define the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of ispinesib in combination with docetaxel.

Conclusion

The study found that the combination of ispinesib and docetaxel can be safely administered, with the MTD defined as ispinesib 10 mg/m² and docetaxel 60 mg/m².

Supporting Evidence

  • The MTD was ispinesib 10 mg/m² with docetaxel 60 mg/m².
  • Twenty-four patients were treated at four dose levels.
  • Prolonged neutropaenia was dose limiting in six patients.

Takeaway

Doctors tested a new cancer treatment combining two drugs, and they found a safe dose that doesn't cause too many side effects.

Methodology

Patients with advanced solid tumors were treated with ispinesib and docetaxel, with dose escalation to determine the MTD and assess safety and efficacy.

Limitations

The study had a small sample size and was limited to specific types of cancer.

Participant Demographics

{"median_age":61.2,"gender_distribution":{"male":21,"female":3},"tumor_types":{"hormone_refractory_prostate_cancer":14,"duodenal_adenocarcinoma":2,"cervical_cancer":2,"bladder_cancer":1,"renal_cancer":2,"colon_cancer":1,"melanoma":1,"esophageal_cancer":1}}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604264

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