PMID- 15122076
OWN - NLM
STAT- MEDLINE
DCOM- 20041122
LR  - 20221207
IS  - 0167-6997 (Print)
IS  - 0167-6997 (Linking)
VI  - 22
IP  - 3
DP  - 2004 Aug
TI  - Phase I/II trial of gemcitabine plus docetaxel in advanced non small cell lung 
      cancer (NSCLC).
PG  - 291-7
AB  - INTRODUCTION: The poor prognosis of non small cell lung cancer (NSCLC), as well 
      as the significant toxicity from many conventional cytotoxic regimens warrants 
      the investigation of combinations of new active agents for treatment. This is a 
      phase I-II (dose-finding, efficacy, and toxicity) study of docetaxel + 
      gemcitabine in patients with stage IIIB-IV NSCLC without prior systemic therapy. 
      PATIENTS were treated in cohorts of 3 with alternating increasing doses of 
      docetaxel and gemcitabine at each level. PATIENTS: Fifty patients were entered, 
      of which 49 were eligible including 28 males and 21 females; 15 stage IIIB and 34 
      stage IV; median age 57 yrs (35-74). RESULTS: The Maximum Tolerated Dose (MTD) 
      was docetaxel 60 mg/m(2) day 1 and gemcitabine 750 mg/m(2) d1 & 8, every 21 days. 
      The overall response rate is 20%. Eight patients are not formally assessable for 
      response due to early discontinuation or loss to follow-up and are considered to 
      have progressive disease. The median time to progression (TTP) is 3.5 months 
      (1-25), with 11 pts with at least 7 months TTP. There were 10 pts (20%) with a 
      partial response (PR); 18 (37%) maintained stable disease; 21 (43%) had 
      progressive disease (PD) or were not assessable. TOXICITY: Forty-nine patients 
      are evaluable for assessment for toxicity: Grade (Gr) 3/4 toxicity was documented 
      thus: 14 with neutropenia, 1 with anemia, 1 with nausea, 2 liver function, 2 
      dyspnea, 2 fatigue, 1 allergy, 1 neurologic. CONCLUSION: This regimen is well 
      tolerated and results in phase I-II testing in this patient population warrant 
      further consideration of the study of docetaxel + gemcitabine for advanced NSCLC.
FAU - Israel, Valerie
AU  - Israel V
AD  - University of Southern California-Kenneth Norris Jr. Comprehensive Cancer Center 
      and California Cancer Medical Center, Los Angeles, CA 90033, USA.
FAU - Tagawa, Scott T
AU  - Tagawa ST
FAU - Snyder, Terry
AU  - Snyder T
FAU - Jeffers, Susan
AU  - Jeffers S
FAU - Raghavan, Derek
AU  - Raghavan D
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Invest New Drugs
JT  - Investigational new drugs
JID - 8309330
RN  - 0 (Taxoids)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 15H5577CQD (Docetaxel)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Cohort Studies
MH  - Deoxycytidine/administration & dosage/*analogs & derivatives
MH  - Docetaxel
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Taxoids/administration & dosage
MH  - Treatment Outcome
MH  - Gemcitabine
EDAT- 2004/05/04 05:00
MHDA- 2004/12/16 09:00
CRDT- 2004/05/04 05:00
PHST- 2004/05/04 05:00 [pubmed]
PHST- 2004/12/16 09:00 [medline]
PHST- 2004/05/04 05:00 [entrez]
AID - 5269623 [pii]
AID - 10.1023/B:DRUG.0000026255.34988.96 [doi]
PST - ppublish
SO  - Invest New Drugs. 2004 Aug;22(3):291-7. doi: 10.1023/B:DRUG.0000026255.34988.96.