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Phase IV Randomized Trial of Pemetrexed Followed by Docetaxel or in Reverse Sequence in Non-small-cell Lung Cancer Patients Failed Previous Chemotherapy

Phase 4
18 Years
Not Enrolling
Non-small-cell Lung Cancer

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Trial Information

Phase IV Randomized Trial of Pemetrexed Followed by Docetaxel or in Reverse Sequence in Non-small-cell Lung Cancer Patients Failed Previous Chemotherapy

Docetaxel was the first third-generation anti-cancer drug found to have activity in
second-line chemotherapy for NSCLC, with a prolongation of patient survival in phase III
randomized trials comparing docetaxel with vinorelbine or ifosfamide, or with the best
supportive care, for NSCLC patients who have failed previous chemotherapy; thus, it has been
recommended for the second-line treatment of NSCLC. Four years after these trials,
pemetrexed showed similar activity with less toxicity, when compared with docetaxel
treatment in a phase III randomized trial of NSCLC patients previously treated with

Pemetrexed is a multitargeted antifolate which exhibits clinical activity in a variety of
solid tumors, especially malignant mesothelioma and NSCLC. It inhibits thymidylate synthase,
dihydrofolate reductase and glycinamide ribonucleotide formyl transferase. Pemetrexed has
confirmed activity against previously chemotherapy-treated NSCLC and has a better toxicity
profile than docetaxel, in which study docetaxel dosage used was 75 mg/m2 intravenous
infusion (IV) every 3 weeks. However, docetaxel dosage used in Japan and Taiwan is usually
60 mg/m2 every 3 weeks.

Whether or not toxicity profiles of these two different drugs in same individual patients is
similar to findings of patients who received specific drug only is unknown, so is unknown of
toxicity profiles of docetaxel 60 mg/m2 every 3 weeks comparing alimta 500 mg/m2 every 3
weeks. Present phase II randomized clinical trial is designed to answer these questions,
with addition of information about whether or not sequential therapy can prolong
disease-free and overall survival.

Inclusion Criteria:

1. histologically or cytologically confirmed non-small cell bronchogenic carcinoma,
inoperable stage IIIB or IV

2. aged 18 years or older

3. failed previous platinum-based chemotherapy

4. presence of at least one measurable disease which is defined as lesion that can be
measured in at least 1 dimension as ≥ 20 mm with conventional CT or ≥ 10 mm with
spiral CT scan

5. performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2

6. white blood cell (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3,
platelets ≥ 100,000/mm3 and hemoglobin ≥ 10 mg / dl

7. serum creatinine level 2.0 mg/dL or lower

8. serum bilirubin less than 1.5 times the upper limit of normal range (ULN)

9. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 times
the ULN (less than 5 times the ULN in liver metastases)

10. written informed consent to participate in the trial In addition, in female patient
with childbearing potential, either terminated by surgery, radiation, or menopause,
or attenuated by use of an approved contraceptive method (intrauterine contraceptive
device [IUD], birth control pills, or barrier device) during and for three months
after trial. Patients who previously treated by surgery are needed to demonstrate
progressive disease before entering the study.

Exclusion Criteria:

1. Active infection (at the discretion of the investigator).

2. Active central nervous system (CNS) metastases.

3. Breast feeding.

4. Serious concomitant systemic disorders incompatible with the study (at the discretion
of the investigator).

5. Use of any investigational agent in the month before enrollment into the study.

6. Concomitant myelosuppressive radiotherapy to target lesion, chemotherapy, hormonal
therapy, or immunotherapy will not be allowed.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of grade III or IV leukopenia during treatment

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Yuh-Min Chen, MD, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chest Department, Taipei VGH


Taiwan: Department of Health

Study ID:




Start Date:

March 2008

Completion Date:

September 2009

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • lung cancer
  • docetaxel
  • pemetrexed
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms