Clinical trial · Interventional
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid
NCT00316225CI-TRIAL-00003654completedPhase 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)
This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.
Conditions
Conditions (3)
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 Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- description
- Pemetrexed 500 mg/m\^2 intravenous (IV) every 21 days for 6 cycles
- interventionNames
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Overview of Adverse Events
- timeFrame
- baseline, up to 18 weeks
- description
- Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) or mesothelioma * Presence of third-space fluid (fluid around the lungs or abdomen). * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the sharp toxic effects the anticancer treatment. * Estimated life expectancy of at least 8 weeks. Exclusion Criteria: * Have received treatment within the last 30 days with a drug that was not a marketed product. * Active infection that, in the opinion of the investigator, would not allow the patient to tolerate therapy. * Pregnancy. * Breast-feeding. * Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry. * Brain metastases.
References
Publications (0)
Data not yet available
No reference posted for this study.