A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
Inclusion Criteria:
Some of the requirements to be in this study are:
- Patient must be at least 18 years old.
- Patient must have been diagnosed with non-small cell lung cancer.
- Patient must be able to visit the doctor's office once a week.
- Patient must have adequate blood, liver, lungs and kidney function within the
requirements of this study.
- Female patients of child-bearing potential must test negative for pregnancy at the
time of enrollment based on a serum pregnancy test. Male and female patients must
agree to use a reliable method of birth control during and for 3 months following the
last dose of study drug.
Exclusion Criteria:
Patients cannot participate in this study for any of the following reasons:
- Patient has previously had chemotherapy.
- Patient has previously had thoracic radiation therapy.
- Patient has received treatment within the last 30 days with a drug that has not
received approval by Health Canada for any indication at the time of study entry.
- Female patient is pregnant or breast-feeding.
- Patient is unsuitable to participate in the study in the opinion of the investigator.
- Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or
dexamethasone.
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:
Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
Outcome Description:
Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.
Outcome Time Frame:
Baseline to measured progressive disease (PD; up to 1 year)
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:
Canada: Health Canada
Study ID:
10259
NCT ID:
NCT00529100
Start Date:
December 2005
Completion Date:
September 2012
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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