A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC
Docetaxel as single-agent therapy (100 mg/m2 and 75 mg/m2, every 3 weeks) produces response
rates of 26% to 54%. Docetaxel has proven superior compared to best supportive care (BSC)
in chemotherapy-naïve as well as in platinum pretreated patients. In addition, docetaxel is
active in cisplatin refractory or resistant patients, producing responses ranging from 18%
to 25%, implying a lack of cross-resistance between docetaxel and cisplatin, probably due to
their different mechanisms of action. Furthermore, docetaxel is associated with significant
prolongation of survival when administered as second line therapy, in pretreated patients
with advanced NSCLC. Phase II studies of pemetrexed in previously untreated patients with
NSCLC have demonstrated single agent response rates of 17% to 23%. A phase II study of
pemetrexed in patients with advanced NSCLC, who had progressed during or within 3 months of
completing first-line chemotherapy, demonstrated a response rate of 8.9% and median survival
time of 5.7 months. Multivariate analysis established an association between an increased
risk of severe pemetrexed toxicity and elevated homocysteine (folate and/or B12 vitamin
deficiency marker) levels. Since December 1999, all pemetrexed-treated patients are required
to receive folic acid and Vitamin B12. A recently reported phase III study compared
pemetrexed with docetaxel as 2nd line therapy in patients with advanced NSCLC. Treatment
with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly
fewer side effects compared with docetaxel.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet
2 years
Yes
Vassilis Georgoulias, MD
Principal Investigator
University Hospital of Crete
Greece: National Organization of Medicines
CT/05.18
NCT00684099
May 2006
May 2009
Name | Location |
---|