Clinical trial · Interventional
Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer
A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
NCT00529100CI-TRIAL-00011239completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin Phase 1 | Drug | — | UNRESOLVED |
| Cisplatin Phase 2 | Drug | — | UNRESOLVED |
| Pemetrexed Phase 1 | Drug | — | UNRESOLVED |
| Pemetrexed Phase 2 | Drug | — | UNRESOLVED |
| Radiation Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pemetrexed/Cisplatin/Radiation Phase 1
- description
- Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m\^2) IV through 500 mg/m\^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m\^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m\^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV.
- interventionNames
- Drug: Pemetrexed Phase 1
- Drug: Cisplatin Phase 1
- Procedure: Radiation Therapy
- type
- EXPERIMENTAL
- label
- Pemetrexed/Cisplatin/Radiation Phase 2
- description
- Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m\^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m\^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m\^2 IV and cisplatin 75 mg/m\^2 IV.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.