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- Title
A Phase I Study of Weekly Gemcitabine and Docetaxel in Patients with Advanced Cancer: A Hoosier Oncology Group Study.
- Authors
Ganjoo, Kristen N.; Gordon, Michael S.; Sandler, Alan B.; Warner, Ruth E.; Fife, Karen; Poirier, Shelley; Seshadri, Roopa; Loehrer, Patrick J.
- 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/m[sup 2] ) and docetaxel (mg/m[sup 2] ) 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/m[sup 2] of gemcitabine and 35 mg/m[sup 2] 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/m[sup 2] , respectively. The DLT was neutropenia. Disease stabilization suggests that this may be an active regimen in patients with metastatic pancreatic cancer.Copyright © 2002 S. Karger AG, Basel
- Subjects
DOCETAXEL; ANTINEOPLASTIC agents; ONCOLOGY; TUMORS; CANCER
- Publication
Oncology, 2002, Vol 62, Issue 4, p299
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000065060