Phase I dose escalation study of gemcitabine plus irinotecan in advanced solid tumors.

Journal Article (Journal Article)

AIM: To determine the maximally tolerated dose (MTD), recommended phase II dose (RPTD) and toxicity profile of gemcitabine plus irinotecan combination. PATIENTS AND METHODS: Thirty-nine evaluable patients with advanced solid tumors were treated with gemcitabine (Gem) and irinotecan (Iri) on days 1, 8 and 15 of a 28-day cycle. Dose levels included Gem/Iri 700/50, 900/50, 900/75, 500/50 mg/m(2) respectively. Dose-limiting toxicity (DLT) was assessed during cycle one; toxicity evaluation was closely monitored throughout the course of treatment. Treatment continued until disease progression or unacceptable toxicity. RESULTS: DLTs primarily consisted of grade > or = 3 thrombocytopenia lasting > or = 4 days often accompanied by grade > or = 3 neutropenia. Other grade > or = 3 toxicities included vomiting, diarrhea, fatigue and elevated alkaline phosphatase. Three patients had a partial response. Stable disease as best response was seen in 16 patients, ranging from 2-18 months. CONCLUSION: The MTD/RPTD is gemcitabine 500 mg/m(2) plus irinotecan 50 mg/m(2) on days 1, 8 and 15 of a 28-day cycle. Given the toxicity profile and negative results of phase III studies, no further testing of this treatment combination is recommended.

Full Text

Duke Authors

Cited Authors

  • Dugan, E; Truax, R; Meadows, KL; Blobe, GC; Morse, MA; Fernando, NH; Gockerman, JP; Petros, WP; Hurwitz, HI

Published Date

  • December 2009

Published In

Volume / Issue

  • 29 / 12

Start / End Page

  • 5149 - 5153

PubMed ID

  • 20044630

Pubmed Central ID

  • PMC4103184

Electronic International Standard Serial Number (EISSN)

  • 1791-7530


  • eng

Conference Location

  • Greece