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A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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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

Type of Study:


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:


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


Canada: Health Canada

Study ID:




Start Date:

December 2005

Completion Date:

September 2012

Related Keywords:

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