A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer

Official Title: “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”

Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.

Intervention(s) in this Clinical Trial

• Drug: pemetrexed
  • 500 mg/m^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles.
• Dietary Supplement: Folic acid
  • 350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed.
• Dietary Supplement: Folic Acid
  • 350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed.
• Dietary Supplement: Vitamin B12
  • 1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
• Drug: dexamethasone
  • 4 mg taken orally [or equivalent] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed.
• Drug: dexamethasone
  • 4 mg taken orally [or equivalent] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Standard Vitamin and Steroid Schedule + Pemetrexed
  • Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
• Experimental: Simplified Vitamin and Steroid Schedule + Pemetrexed
  • Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.

Primary Measures

• Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity
  • Time Frame: From first dose of treatment to last dose of treatment plus 30 days
    Safety Issue?: Yes

Secondary Measures

• Proportion of Participants With Best Overall Tumor Response (Response Rate)
  • Time Frame: Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.
    Safety Issue?: No
• Overall Survival
  • Time Frame: Randomization (≤4 weeks from baseline visit) to 12 months after randomization
    Safety Issue?: Yes
• Progression-free Survival (PFS)
  • Time Frame: Randomization (≤4 weeks from baseline visit) to 12 months after randomization
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00609518

Study ID Number: 11652

ClinicalTrials.gov Identifier: NCT00609518

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Lilly Clinical Trial Registry