Pemetrexed Followed by Docetaxel or in Reverse Sequence

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Both pemetrexed and docetaxel have been reported to have similar activity against non-small cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III study. However, no study showed different toxicity and efficacy profiles within individual patients. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Docetaxel; Pemetrexed

Criteria

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.