Know Cancer

or
forgot password

Pemetrexed With Simplified Folate and Dexamethasone Supplementation Versus Pemetrexed With Standard Supplementation as Second-line Chemotherapy for Patients With Non-squamous Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

Pemetrexed With Simplified Folate and Dexamethasone Supplementation Versus Pemetrexed With Standard Supplementation as Second-line Chemotherapy for Patients With Non-squamous Non-small Cell Lung Cancer


Inclusion Criteria:



- Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally
advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous
histology

- Patients must have failed only one prior chemotherapy regime and must be considered
eligible for further chemotherapy following progression of their disease.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- Adequate organ function

Exclusion Criteria:

- Concurrent administration of any other anti-tumor therapy

- Other co-existing malignancies

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

Outcome Measure:

Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity

Outcome Description:

Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.

Outcome Time Frame:

From first dose of treatment to last dose of treatment plus 30 days

Safety Issue:

Yes

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:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

11652

NCT ID:

NCT00609518

Start Date:

February 2008

Completion Date:

June 2010

Related Keywords:

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

Name

Location