Phase 2
Completed N=49
Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00529100 ↗Enrolled (actual)
49
Serious AEs
28.6%
Results posted
Sep 2011
Primary outcomePrimary: 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)
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.
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 | — |
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. Informational only — not medical advice.