Phase I/pharmacokinetic/biochemical study of the nitroimadazole hypoxic cell sensitiser SR2508 (etanidazole) in combination with cyclophosphamide
1993

Study of SR2508 and Cyclophosphamide in Cancer Treatment

Sample size: 46 publication Evidence: moderate

Author Information

Author(s): P.J. O'Dwyer, F.P. LaCreta, J. Walczak, T. Cox, S. Litwin, J.P. Hoffman, M. Zimny, R.L. Comis

Primary Institution: Fox Chase Cancer Center

Hypothesis

The study aims to determine the maximum tolerated dose of SR2508 when combined with cyclophosphamide and to evaluate its effects on glutathione levels and pharmacokinetics.

Conclusion

The maximum tolerated dose of SR2508 was found to be 12.2 g m-2, with neurotoxicity being the dose-limiting factor.

Supporting Evidence

  • SR2508 sensitizes hypoxic tumor cells to radiation and alkylating agents.
  • Patients experienced myelosuppression as a major toxicity.
  • Neurotoxicity was dose-limiting at higher doses of SR2508.

Takeaway

Doctors tested a new drug called SR2508 to see how much they could safely give it to cancer patients when used with another drug, cyclophosphamide, and found that too much could cause nerve pain.

Methodology

Patients received cyclophosphamide followed by SR2508 at various doses, with monitoring of side effects and pharmacokinetics.

Potential Biases

Potential bias due to the study being conducted at a single institution.

Limitations

The study had a small sample size and focused on short-term effects.

Participant Demographics

The study included 47 patients, with a median age of 60 years, consisting of 28 males and 19 females.

Statistical Information

P-Value

p<0.01

Statistical Significance

p<0.01

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