Phase I study of weekly cisplatin, bolus fluorouracil and escalating doses of irinotecan in advanced solid tumors Journal Article


Authors: Ku, G. Y.; O'Reilly, E. M.; Saltz, L. B.; Schrag, D.; Maki, R. G.; Kelsen, D. P.; Ilson, D. H.
Article Title: Phase I study of weekly cisplatin, bolus fluorouracil and escalating doses of irinotecan in advanced solid tumors
Abstract: We performed a phase I study of 5-fluorouracil (5-FU), cisplatin and irinotecan. Methods: Twenty-nine patients received cisplatin 25 mg/m<sup>2</sup> and bolus 5-FU 425 mg/m<sup>2</sup>, along with irinotecan at 40, 50, and 65 mg/m<sup>2</sup> weekly for 4 out of 6 weeks. Results: The maximum tolerated dose (MTD) for untreated patients was irinotecan 65 mg/m<sup>2</sup> while the MTD for previously treated patients was irinotecan 40 mg/m<sup>2</sup>. Neutropenia and diarrhea were the major dose-limiting toxicities. Antitumor activity was noted in gastric, esophageal and pancreatic cancers. Conclusion: Because of the toxicity profile, combinations with continuous infusion 5-FU or capecitabine should be explored. ©Informa Healthcare USA.
Keywords: adult; clinical article; treatment outcome; aged; middle aged; clinical trial; constipation; disease course; fatigue; neutropenia; cisplatin; fluorouracil; advanced cancer; cancer combination chemotherapy; diarrhea; drug dose reduction; side effect; solid tumor; treatment duration; capecitabine; pancreas cancer; pancreatic neoplasms; drug megadose; antineoplastic agent; low drug dose; multiple cycle treatment; erythropoietin; anemia; leukopenia; nausea; neuropathy; antineoplastic combined chemotherapy protocols; drug administration schedule; camptothecin; dexamethasone; antineoplastic activity; continuous infusion; pathology; time; time factors; irinotecan; abdominal pain; drug dose escalation; febrile neutropenia; fever; prothrombin time; disease progression; chemically induced disorder; thrombosis; pancreas tumor; drug derivative; granisetron; stomach cancer; loperamide; maximum tolerated dose; phase 1 clinical trial; drug administration; recombinant granulocyte colony stimulating factor; esophagus cancer; 5-fluorouracil; infusions, intravenous; stomach neoplasms; esophagus tumor; esophageal neoplasms; phase i trial; atropine; digestive system tumor; intravenous drug administration; stomach tumor; digestive system neoplasms; injections, intravenous
Journal Title: Cancer Investigation
Volume: 27
Issue: 4
ISSN: 0735-7907
Publisher: Informa Healthcare  
Date Published: 2009-04-01
Start Page: 402
End Page: 406
Language: English
DOI: 10.1080/07357900802406327
PUBMED: 19219674
PROVIDER: scopus
DOI/URL:
Notes: --- - "Export Date: 30 November 2010" - "CODEN: CINVD" - "Source: Scopus"
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MSK Authors
  1. Leonard B Saltz
    790 Saltz
  2. Deborah Schrag
    229 Schrag
  3. Geoffrey Yuyat Ku
    230 Ku
  4. Robert Maki
    238 Maki
  5. David H Ilson
    433 Ilson
  6. Eileen O'Reilly
    780 O'Reilly
  7. David P Kelsen
    537 Kelsen