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Difluorodeoxycytidine (dFdC)--gemcitabine: a phase I study.

E A Poplin1, T Corbett, L Flaherty

  • 1Department of Internal Medicine, Wayne State University School of Medicine, Detroit, Michigan 48202-0188.

Investigational New Drugs
|August 1, 1992
PubMed
Summary
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Difluorodeoxycytidine (dFdC) showed promise in preclinical cancer models. Phase 1 trials revealed dose-limiting toxicities including marrow suppression and flu-like symptoms, with one partial response observed.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Difluorodeoxycytidine (dFdC) exhibited broad-spectrum anticancer activity in preclinical studies.
  • A Phase 1 clinical trial was initiated to evaluate the safety and tolerability of dFdC.

Purpose of the Study:

  • To determine the maximum tolerated dose (MTD) of dFdC.
  • To assess dose-limiting toxicities (DLTs) associated with dFdC administration.
  • To explore preliminary efficacy signals of dFdC in cancer patients.

Main Methods:

  • A Phase 1, open-label, dose-escalation study was conducted.
  • Fifty eligible patients received dFdC via twice-weekly intravenous infusion (29 patients) or bolus injection (22 patients).
  • Dose escalation ranged from 5-90 mg/m2 for infusion and 30-150 mg/m2 for bolus.

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Main Results:

  • The primary dose-limiting toxicities identified were myelosuppression and flu-like symptoms.
  • Thrombocytopenia was the dose-limiting toxicity at 75 mg/m2 (infusion) and 150 mg/m2 (bolus).
  • One patient with renal cell carcinoma achieved a partial response.

Conclusions:

  • dFdC exhibits a toxicity profile characterized by marrow suppression and flu-like symptoms.
  • Further evaluation is needed to determine the optimal dosing schedule and efficacy of dFdC.
  • Schedule dependency of dFdC's efficacy warrants continued investigation.