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A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC

Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

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.

Inclusion Criteria:

- Histologically confirmed inoperable (stage IIIB-IV) NSCLC. A block of Formaline Fixed
Parafine Embedded tissue representative for the primary diagnosis should be available
for genomic analysis (phase II part)

- Written informed consent

- Prior chemotherapy with platinum compounds in association with or without taxanes
(phase I part)

- Previously untreated with docetaxel and pemetrexed (phase II part)

- Bidimensionally, non-irradiated measurable disease (according to RECIST criteria)
(phase II)

- Age ≥18 years

- World Health Organization (WHO) performance status (PS) 0-2

- Life expectancy of at least 12 weeks

- Serum bilirubin less than 1.5 times the upper normal limit (UNL)

- AST and ALT less than 2.5 times the UNL in the absence of demonstrable liver
metastases, or less than 5 times the UNL in the presence of liver metastases.

- Serum creatinine less than 1.5 times the UNL

- Neutrophil count more than 1.5x 109 /L

- Platelet count more than 100x 109 /L

Exclusion Criteria:

- Other co-existing malignancies or malignancies diagnosed within the last 5 years
(with the exception of basal cell carcinoma or cervical cancer in situ)

- Any evidence of severe uncontrolled concomitant disease (in the opinion of the

- Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer

- Patients with unstable central nervous system metastases

- Malnutrition (loss of ≥ 20% of the original body weight)

- Performance status: 4

- Psychiatric illness or social situation that would preclude study compliance

- Pregnant or lactating women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Vassilis Georgoulias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete


Greece: National Organization of Medicines

Study ID:




Start Date:

May 2006

Completion Date:

May 2009

Related Keywords:

  • Non Small Cell Lung Cancer
  • Pemetrexed
  • Docetaxel
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms