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Phase I and pharmacologic study of weekly amrubicin in patients with refractory or relapsed lung cancer: Central Japan Lung Study Group (CJLSG) 0601 trial.

AbstractPURPOSE:
To evaluate the safety and tolerability of amrubicin (AMR), determine its maximum tolerated dose (MTD), its dose-limiting toxicities (DLTs), and its recommended dose (RD), and to conduct a pharmacokinetic study of weekly AMR administrations in patients with chemotherapy-refractory or recurrent small cell or non-small cell lung cancer.
PATIENTS AND METHODS:
Patients with refractory or relapsed non-small cell and small cell lung cancer after 1 or 2 regimens of chemotherapy were eligible. AMR was initiated at 45 mg/m(2) weekly (repetition of dose on 1st and 8th day with a rest on day 15). The dose level was increased by 5 mg/m(2) by modified Fibonacci dose escalation scheme.
RESULTS:
Seven patients had small cell lung cancer and 9 had non-small cell lung cancer. Fifty-four courses (median: 3, range: 1-6) were administered at 5 dose levels. At 65 mg/m(2), 3 patients had DLTs as follows: 1 was grade 3 (CTCAE v3.0) in AST/ALT, 1 was grade 3 febrile neutropenia, and 1 was grade 4 neutropenia. Leukocytopenia and neutropenia were correlated with amrubicinol (AMR-OH) C (max) (P = 0.042, P = 0.047, respectively). The AUC (area under the curve of plasma concentration versus time extrapolated to concentration zero) of AMR and AMR-OH did not depend on the dose levels.
CONCLUSION:
In the present phase I study of AMR administered weekly to previously treated lung cancer patients, the maximum tolerated dose and RD were 65 and 60 mg/m(2), respectively. The best response rate was 15.4%, and adverse events with this schedule were tolerable.
AuthorsChiyoe Kitagawa, Hideo Saka, Shigehisa Kajikawa, Kouki Mori, Masahide Oki, Ryujiro Suzuki
JournalCancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 69 Issue 5 Pg. 1379-85 (May 2012) ISSN: 1432-0843 [Electronic] Germany
PMID22237957 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study)
Chemical References
  • Anthracyclines
  • Antineoplastic Agents
  • amrubicin
Topics
  • Adult
  • Aged
  • Anthracyclines (administration & dosage, adverse effects, pharmacokinetics)
  • Antineoplastic Agents (administration & dosage, adverse effects, pharmacokinetics)
  • Area Under Curve
  • Carcinoma, Non-Small-Cell Lung (drug therapy, pathology)
  • Carcinoma, Small Cell (drug therapy, pathology)
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Lung Neoplasms (drug therapy, pathology)
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Recurrence, Local

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