A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00609518
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Vitamin and Steroid Schedule + Pemetrexed Folic Acid 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. Standard Vitamin and Steroid Schedule + Pemetrexed Vitamin B12 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. Simplified Vitamin and Steroid Schedule + Pemetrexed Folic Acid 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. Simplified Vitamin and Steroid Schedule + Pemetrexed Vitamin B12 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. Standard Vitamin and Steroid Schedule + Pemetrexed 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. Simplified Vitamin and Steroid Schedule + Pemetrexed 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. Standard Vitamin and Steroid Schedule + Pemetrexed dexamethasone 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. Simplified Vitamin and Steroid Schedule + Pemetrexed dexamethasone 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 Outcome Measures
Name Time Method Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity From first dose of treatment to last dose of treatment plus 30 days 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.
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Best Overall Tumor Response (Response Rate) Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment. Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response.
Overall Survival Randomization (≤4 weeks from baseline visit) to 12 months after randomization Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.
Progression-free Survival (PFS) Randomization (≤4 weeks from baseline visit) to 12 months after randomization Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇪🇸Sevilla, Spain