A phase I study of weekly gemcitabine and docetaxel in patients with advanced cancer: A Hoosier Oncology Group study

Kristen N. Ganjoo, Michael S. Gordon, Alan B. Sandler, Ruth E. Warner, Karen Fife, Shelley Poirier, Roopa Seshadri, Patrick Loehrer

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Purpose: To determine the maximum tolerated dose (MTD) of weekly gemcitabine plus docetaxel, a dose escalation trial of both drugs was developed with each administered weekly for 3 weeks out of 4. Patients and Methods: Dose levels for gemcitabine (mg/m2) and docetaxel (mg/m2) were as follows: level 1: 600/25; level 2: 600/35; level 3: 750/35; and level 4: 900/35. Sixteen patients with adequate renal, hepatic, and hematologic function and an Eastern Cooperative Oncology Group performance status of 0-2 were treated. Primary sites included pancreas (12) and others (4). Results: Three patients were treated at each dose level from level 1 through level 4. The dose-limiting toxicity (DLT) was neutropenia, the maximum tolerated dose being 750 mg/m2 of gemcitabine and 35 mg/m2 of docetaxel. No grade 4 nonhematologic toxicity was seen. Three patients had grade 4 neutropenia. Of the 12 patients with pancreatic cancer, 1 had a partial remission and 7 had stable disease with a median duration of 8 weeks. Conclusions: Gemcitabine and docetaxel can be safely administered weekly at a dose of 750 and 35 mg/m2, respectively. The DLT was neutropenia. Disease stabilization suggests that this may be an active regimen in patients with metastatic pancreatic cancer.

Original languageEnglish
Pages (from-to)299-304
Number of pages6
JournalOncology
Volume62
Issue number4
DOIs
StatePublished - 2002

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docetaxel
gemcitabine
Neutropenia
Neoplasms
Maximum Tolerated Dose
Pancreatic Neoplasms
Pancreas
Kidney

Keywords

  • Docetaxel
  • Gemcitabine
  • Phase I
  • Weekly

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A phase I study of weekly gemcitabine and docetaxel in patients with advanced cancer : A Hoosier Oncology Group study. / Ganjoo, Kristen N.; Gordon, Michael S.; Sandler, Alan B.; Warner, Ruth E.; Fife, Karen; Poirier, Shelley; Seshadri, Roopa; Loehrer, Patrick.

In: Oncology, Vol. 62, No. 4, 2002, p. 299-304.

Research output: Contribution to journalArticle

Ganjoo, KN, Gordon, MS, Sandler, AB, Warner, RE, Fife, K, Poirier, S, Seshadri, R & Loehrer, P 2002, 'A phase I study of weekly gemcitabine and docetaxel in patients with advanced cancer: A Hoosier Oncology Group study', Oncology, vol. 62, no. 4, pp. 299-304. https://doi.org/10.1159/000065060
Ganjoo, Kristen N. ; Gordon, Michael S. ; Sandler, Alan B. ; Warner, Ruth E. ; Fife, Karen ; Poirier, Shelley ; Seshadri, Roopa ; Loehrer, Patrick. / A phase I study of weekly gemcitabine and docetaxel in patients with advanced cancer : A Hoosier Oncology Group study. In: Oncology. 2002 ; Vol. 62, No. 4. pp. 299-304.
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