Phase 2
N=49
Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00529100 ↗Enrolled (actual)
49
Serious AEs
28.6%
Results posted
Sep 2011
Primary outcome: Primary: Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy — 500; 20; 500; 75 milligrams per square meter (mg/m^2)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pemetrexed Phase 1 (Drug); Cisplatin Phase 1 (Drug); Radiation Therapy (Procedure); Pemetrexed Phase 2 (Drug); Cisplatin Phase 2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy |
500; 20; 500; 75 | — |
| PRIMARY Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year |
79.0 | — |
| SECONDARY Phase 1: Number of Participants With Adverse Events (AE; Toxicity) |
5; 10 | — |
| SECONDARY Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years |
56.4; 46.2 | — |
| SECONDARY Phase 2: Time to Progressive Disease (PD) |
13.7 | — |
| SECONDARY Phase 2: Percentage of Participants With Progression Free Survival (PFS) |
48.7; 30.8; 20.2 | — |
| SECONDARY Progression Free Survival (PFS) |
11.8 | — |
| SECONDARY Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate) |
0; 45.95 | — |
| SECONDARY Phase 2: Site of Progressive Disease (PD) |
8; 17; 1; 1 | — |
Summary
Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00529100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.