PMID- 15639725
OWN - NLM
STAT- MEDLINE
DCOM- 20050412
LR  - 20221207
IS  - 0169-5002 (Print)
IS  - 0169-5002 (Linking)
VI  - 47
IP  - 2
DP  - 2005 Feb
TI  - Innovative sequence of docetaxel-gemcitabine based on preclinical data in the 
      treatment of advanced non small cell lung cancer: a phase I study.
PG  - 261-7
AB  - Based on our previous preclinical data, a phase I study was designed to 
      investigate the tolerability of a novel sequence, docetaxel (DOC)-gemcitabine 
      (GEM), in the treatment of non small cell lung cancer (NSCLC). Preclinical study: 
      We evaluated the cytotoxicity of DOC and GEM on NSCLC cell lines and assessed the 
      type of interaction between drug activities following different treatment 
      schemes. Clinical study: Fifteen patients with stage IIIB-IV NSCLC received DOC 
      (day 1) and GEM (days 3 and 8) every 21 days. Dose escalation of both agents was 
      used to identify the maximum tolerated dose. The study was closed at the fifth 
      dose level due to the occurrence of three dose-limiting toxicities: grade 4 
      febrile neutropoenia, persistent grade 2 fever and grade 3 diarrhoea. The most 
      frequent toxicity was neutropoenia. Non haematological toxicities were diarrhoea, 
      nausea and vomiting, mucositis and alopoecia. Of the 14 evaluable patients, 1 
      complete response, 4 partial responses, 4 stable diseases and 5 disease 
      progressions were observed. Based on the results of the present study, a phase II 
      trial is ongoing using the fourth dose levels.
FAU - Ibrahim, Toni
AU  - Ibrahim T
AD  - Department of Medical Oncology, Pierantoni Hospital, Via Forlanini 34, 47100 
      Forli, Italy.
FAU - Zoli, Wainer
AU  - Zoli W
FAU - Frassineti, Giovanni Luca
AU  - Frassineti GL
FAU - Tesei, Anna
AU  - Tesei A
FAU - Colantonio, Ida
AU  - Colantonio I
FAU - Monti, Manuela
AU  - Monti M
FAU - Amadori, Dino
AU  - Amadori D
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Journal Article
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0 (Taxoids)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 15H5577CQD (Docetaxel)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse 
      effects/pharmacology/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology
MH  - Cell Cycle/drug effects
MH  - Deoxycytidine/administration & dosage/*analogs & derivatives
MH  - Disease Progression
MH  - Docetaxel
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neutropenia/chemically induced
MH  - Taxoids/administration & dosage
MH  - Tumor Cells, Cultured
MH  - Gemcitabine
EDAT- 2005/01/11 09:00
MHDA- 2005/04/13 09:00
CRDT- 2005/01/11 09:00
PHST- 2004/03/01 00:00 [received]
PHST- 2004/06/10 00:00 [revised]
PHST- 2004/06/16 00:00 [accepted]
PHST- 2005/01/11 09:00 [pubmed]
PHST- 2005/04/13 09:00 [medline]
PHST- 2005/01/11 09:00 [entrez]
AID - S0169-5002(04)00307-1 [pii]
AID - 10.1016/j.lungcan.2004.06.011 [doi]
PST - ppublish
SO  - Lung Cancer. 2005 Feb;47(2):261-7. doi: 10.1016/j.lungcan.2004.06.011.