A dose escalation study of gemcitabine plus pemetrexed administered biweekly in patients with solid tumors.
OBJECTIVE
The study aimed to determine the maximum tolerated doses (MTDs) and identify the dose-limiting toxicities of the biweekly administration of pemetrexed plus gemcitabine in patients with solid tumors.


METHODS
Patients with advanced malignancies were treated with escalated doses of gemcitabine and pemetrexed (starting doses 1,250 and 300 mg/m(2), respectively) both given on days 1 and 15 in cycles of 4 weeks.


RESULTS
Forty-one patients were treated at 7 dose levels. The MTD was reached at the dose of 1,750 mg/m(2) for gemcitabine and 450 mg/m(2) for pemetrexed. Dose-limiting events were grade IV neutropenia, febrile neutropenia and treatment delay due to grade III hematological toxicities. One partial response in a pretreated patient with ovarian cancer was observed, while 4 other patients experienced stable disease.


CONCLUSIONS
The biweekly administration of gemcitabine plus pemetrexed at the recommended MTDs is safe, well tolerated and demonstrates antitumor activity which merits further evaluation in phase II studies.
Kalykaki
A
A
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece.
Vamvakas
L
L
Agelaki
S
S
Kalbakis
K
K
Vardakis
N
N
Sfakiotaki
G
G
Ignatiadis
M
M
Saridaki
Z
Z
Karampeazis
A
A
Karabeazis
A
A
Mavroudis
D
D
Georgoulias
V
V
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005971:Glutamates / Q000008:administration & dosage* / Q000009:adverse effects; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D000068437:Pemetrexed; D000093542:Gemcitabine
D005971:Glutamates; D000068437:Pemetrexed; D003841:Deoxycytidine; D006147:Guanine; D000093542:Gemcitabine