Abstract | PURPOSE: 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: 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.
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Authors | Chiyoe Kitagawa, Hideo Saka, Shigehisa Kajikawa, Kouki Mori, Masahide Oki, Ryujiro Suzuki |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 69
Issue 5
Pg. 1379-85
(May 2012)
ISSN: 1432-0843 [Electronic] Germany |
PMID | 22237957
(Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study)
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Chemical References |
- Anthracyclines
- Antineoplastic Agents
- amrubicin
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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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