A dose escalation study of gemcitabine plus pemetrexed administered biweekly in patients with solid tumors.

Abstract

PURPOSE:

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.

PATIENTS AND 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.

• Authors: A Kalykaki, L Vamvakas, S Agelaki, K Kalbakis, N Vardakis, G Sfakiotaki, M Ignatiadis, Z Saridaki, A Karampeazis, A Karabeazis, D Mavroudis, V Georgoulias
• Journal: Oncology (Oncology) Vol. 71 Issue 3-4 Pg. 197-203 ( 2006) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 17641541 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright (c) 2006 S. Karger AG, Basel.

Chemical References

• Glutamates
• Pemetrexed
• Deoxycytidine
• Guanine
• Gemcitabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Female
• Glutamates (administration & dosage, adverse effects)
• Guanine (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasms (drug therapy)
• Pemetrexed
• Gemcitabine