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Open-Label Single-Arm Phase IV Study of Pemetrexed in Taiwanese Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

Open-Label Single-Arm Phase IV Study of Pemetrexed in Taiwanese Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy


Inclusion Criteria:



- Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or
IV)

- Patients' NSCLC must have progressed following one chemotherapy regimen for
palliative therapy with or without subsequent targeted biological therapy

- Disease status must be that of measureable disease as defined by Response Evaluation
Criteria In Solid Tumors (RECIST) criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria:

- Concurrent administration of any other tumor therapy

- Pregnancy or breast feeding

- Serious concomitant disorders

- Inability or unwillingness to take folic acid or vitamin B12 supplementation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])

Outcome Description:

The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.

Outcome Time Frame:

baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Taiwan: Department of Health

Study ID:

10720

NCT ID:

NCT00380718

Start Date:

November 2006

Completion Date:

November 2009

Related Keywords:

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

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