Irinotecan and gemcitabine in patients with solid tumors: phase I trial.

Caio Max S Rocha Lima, Swan Swan Leong, Carol A. Sherman, Joshua A. Perkel, Terri Putman, Ahmad R. Safa, Mark R. Green

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Abstract

Using a day 1 and 8, every-3-week schedule, our purpose was to determine the maximum tolerated dose of irinotecan (CPT-11, Camptosar) that can be administered immediately after gemcitabine (Gemzar) at a dose of 1,000 mg/m2 IV. In this phase I trial, the maximum tolerated dose was defined as the dose level immediately below the level in which two of the first three patients in any cohort, or at least two of six patients in any expanded cohort, experienced dose-limiting toxicity. Dose-limiting toxicity pertained only to toxicity during the first cycle of treatment. Escalation of irinotecan was planned in groups of three patients, with three additional patients added at the first indication of dose-limiting toxicity. A total of 19 patients have been enrolled. Grade 4 diarrhea was the dose-limiting toxicity at the irinotecan dose of 115 mg/m2. Hematologic toxicity was not dose limiting. Three patients required canceling of the day 8 dose due to grade 3 myelosuppression. Three patients, two with pancreatic cancer and one with metastatic carcinoma of unknown primary, had a partial response. The maximum tolerated dose of irinotecan in this combination was 100 mg/m2/dose. The dose-limiting toxicity was diarrhea. The maximum tolerated dose is the recommended starting dose for phase II studies.

Original languageEnglish
JournalOncology (Williston Park, N.Y.)
Volume16
Issue number5 Suppl 5
StatePublished - May 1 2002

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irinotecan
gemcitabine
Maximum Tolerated Dose
Neoplasms
Diarrhea
Pancreatic Neoplasms

ASJC Scopus subject areas

  • Oncology

Cite this

Lima, C. M. S. R., Leong, S. S., Sherman, C. A., Perkel, J. A., Putman, T., Safa, A. R., & Green, M. R. (2002). Irinotecan and gemcitabine in patients with solid tumors: phase I trial. Oncology (Williston Park, N.Y.), 16(5 Suppl 5).

Irinotecan and gemcitabine in patients with solid tumors : phase I trial. / Lima, Caio Max S Rocha; Leong, Swan Swan; Sherman, Carol A.; Perkel, Joshua A.; Putman, Terri; Safa, Ahmad R.; Green, Mark R.

In: Oncology (Williston Park, N.Y.), Vol. 16, No. 5 Suppl 5, 01.05.2002.

Research output: Contribution to journalArticle

Lima, CMSR, Leong, SS, Sherman, CA, Perkel, JA, Putman, T, Safa, AR & Green, MR 2002, 'Irinotecan and gemcitabine in patients with solid tumors: phase I trial.', Oncology (Williston Park, N.Y.), vol. 16, no. 5 Suppl 5.
Lima CMSR, Leong SS, Sherman CA, Perkel JA, Putman T, Safa AR et al. Irinotecan and gemcitabine in patients with solid tumors: phase I trial. Oncology (Williston Park, N.Y.). 2002 May 1;16(5 Suppl 5).
Lima, Caio Max S Rocha ; Leong, Swan Swan ; Sherman, Carol A. ; Perkel, Joshua A. ; Putman, Terri ; Safa, Ahmad R. ; Green, Mark R. / Irinotecan and gemcitabine in patients with solid tumors : phase I trial. In: Oncology (Williston Park, N.Y.). 2002 ; Vol. 16, No. 5 Suppl 5.
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