Status:
COMPLETED
Pemetrexed Followed by Docetaxel or in Reverse Sequence
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- histologically or cytologically confirmed non-small cell bronchogenic carcinoma, inoperable stage IIIB or IV
- aged 18 years or older
- failed previous platinum-based chemotherapy
- 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
- performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
- white blood cell (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 10 mg / dl
- serum creatinine level 2.0 mg/dL or lower
- serum bilirubin less than 1.5 times the upper limit of normal range (ULN)
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 times the ULN (less than 5 times the ULN in liver metastases)
- 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
- Active infection (at the discretion of the investigator).
- Active central nervous system (CNS) metastases.
- Breast feeding.
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Use of any investigational agent in the month before enrollment into the study.
- Concomitant myelosuppressive radiotherapy to target lesion, chemotherapy, hormonal therapy, or immunotherapy will not be allowed.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01442909
Start Date
March 1 2008
End Date
September 1 2009
Last Update
September 29 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Taipei VGH
Taipei, Taiwan, 112