A phase I study of gemcitabine and docetaxel for advanced stage solid tumors.
BACKGROUND
We conducted a phase I study to determine the maximum tolerated dose of docetaxel in combination with gemcitabine for patients with refractory solid tumors.


METHODS
From January 1998 to November 1999, we treated 28 patients on a phase I protocol with gemcitabine given at a constant dose of 800 mg/m2 i.v. over 30 minutes on days 1, 8, and 15. Docetaxel was administered by a phase I schedule over 1 hour on day 1 of a 28-day cycle with a starting dose of 50 mg/m2 and increased by increments of 10 mg/m2 based on dose-limiting toxicity (DLT) that occurred in the first cycle.


RESULTS
Neutropenia and thrombocytopenia were the dose-limiting toxicities. The maximum tolerated dose was 60 mg/m2. The most significant nonhematologic toxicities included fatigue, nausea, vomiting, mucositis, and hypersensitivity reactions. There was one partial response at 15 months in a patient with gastric cancer and six patients with stable disease for 4.0 to 15.0 months.


CONCLUSIONS
The maximum tolerated dose of docetaxel with gemcitabine is 60 mg/m2. A Phase II study in selected primary sites is planned.
Poole
Michael E
ME
Division of Hematology/Oncology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. poolem@med.unc.edu
Bernard
Stephen A
SA
Churchel
Mary Ann
MA
Weissler
Mark C
MC
Calvo
Benjamin
B
Cance
William
W
Ollila
David
D
Koruda
Mark
M
Behrns
Kevin
K
Detterbeck
Frank C
FC
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D003841:Deoxycytidine / Q000009:adverse effects* / Q000031:analogs & derivatives*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000145:classification / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000009:adverse effects* / Q000031:analogs & derivatives*; D018579:Patient Selection; D043823:Taxoids; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine