Abstract | PURPOSE: PATIENTS AND METHODS: Eleven patients with stage IIIB or IV disease were treated at 3-week intervals with amrubicin (5-min intravenous injection on days 1-3) plus 60 mg/m2 of CPT-11 (90-min intravenous infusion on days 1 and 8). The starting dose of amrubicin was 25 mg/m2, and it was escalated in 5 mg/m2 increments until the maximum tolerated dose was reached. RESULTS: The 30 mg/m2 of amrubicin dose was one dose level above the MTD, since three of the five patients experienced DLT during the first cycle of treatment at this dose level. Diarrhea and leukopenia were the DLT, while thrombocytopenia was only a moderate problem. Amrubicin did not affect the pharmacokinetics of CPT-11, SN-38 or SN-38 glucuronide. Except for one patient, the biliary index on day-1 correlated well with the percentage decrease of neutrophils in a sigmoid Emax model. There were five partial responses among 11 patients for an overall response rate of 45%. CONCLUSION:
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Authors | Tomoko Yanaihara, Masanori Yokoba, Sayaka Onoda, Michiko Yamamoto, Shinichiro Ryuge, Shintaro Hagiri, Masato Katagiri, Mayuko Wada, Hisashi Mitsufuji, Masaru Kubota, Susumu Arai, Hirosuke Kobayashi, Nobuo Yanase, Tadashi Abe, Noriyuki Masuda |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 59
Issue 4
Pg. 419-27
(Mar 2007)
ISSN: 0344-5704 [Print] Germany |
PMID | 16832665
(Publication Type: Clinical Trial, Phase I, Journal Article)
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Chemical References |
- Anthracyclines
- Irinotecan
- amrubicin
- Camptothecin
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Topics |
- Anthracyclines
(administration & dosage, adverse effects, pharmacokinetics)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Camptothecin
(administration & dosage, adverse effects, analogs & derivatives, pharmacokinetics)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, mortality)
- Female
- Humans
- Irinotecan
- Lung Neoplasms
(drug therapy, mortality)
- Male
- Middle Aged
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