Clinical trial · Interventional
Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer
A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed
NCT00280748CI-TRIAL-00028248NRRterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving whole-brain radiation therapy together with pemetrexed works in treating patients with brain metastases from non-small cell lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm Study
- description
- Single Arm Study
- interventionNames
- Drug: pemetrexed disodium
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Response of Intracranial Metastases (Complete and Partial Response)
- timeFrame
- 126 days
- description
- Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Must have evidence of brain metastases by MRI or CT scan PRIOR CONCURRENT THERAPY: * Recovered from prior oncologic or major surgery * Prior resection of all brain metastases or only site of brain metastases allowed provided there is radiologically evaluable intracranial metastases * No prior cranial irradiation, including stereotactic radiosurgery * More than 30 days since prior non-approved or investigational drug * No other concurrent chemotherapy, immunotherapy, hormonal therapy, radiotherapy, surgery, or experimental medications * No single brain metastases or oligometastatic disease amenable to surgical resection or radiosurgery * Relapsed NSCLC with brain metastases allowed * Not a candidate for double-agent or platinum-based chemotherapy * No leptomeningeal metastases * No clinically relevant (defined by physical exam) pleural effusions or ascites that cannot be controlled with drainage or other procedures Inclusion Criteria: * Karnofsky performance status 70-100% OR ≥ 70 years of age * Life expectancy \> 3 months * Absolute neutrophil count (ANC) \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin ≥ 8 g/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Creatinine clearance ≥ 45 mL/min * Able to take vitamins, folic acid, and corticosteroids Exclusion Criteria: * Contraindication or intolerance to corticosteroid therapy * Other malignancies within the past 5 years and disease-free OR prognosis is best defined by the NSCLC in the opinion of the attending physician * Pregnant or nursing * Positive pregnancy test * Fertile patients must use effective contraception * HIV positive * Severe hypersensitivity to pemetrexed disodium * Unable to discontinue NSAIDs for ≥ 5 days * History of underlying dementia, Parkinson's disease, or Alzheimer's disease
References
Publications (0)
Data not yet available
No reference posted for this study.