Clinical trial · Interventional
Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
NCT00198133CI-TRIAL-00039602completedPhase 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)
To study the efficacy of Alimta as a single agent in thymic cancers
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 |
|---|---|---|---|
| Thymic Carcinoma | Thymus Carcinoma | CURATED_BROADER | 0.80 |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Premetrexed (Alimta) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- description
- Pemetrexed infusion once every 21 days (one cycle).
- interventionNames
- Drug: Premetrexed (Alimta)
Primary outcomes (1)
- measure
- Objective Response Rate (Complete and Partial Response)
- timeFrame
- Up to 3 years
- description
- The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.
Secondary outcomes (2)
- measure
- Duration of Remission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated. * Patients must have measurable disease with at least one bidimensional measurable lesion. Any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration. * Patients may have had prior chemotherapy for metastatic disease * Adequate organ function as defined by: bili \</=1.5; calc. crt clr of \>/=45; hematologic-granulocytes \>/=1500 \& plt \>/=100K. * Patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible. * ECOG performance status of 0 or 1 Exclusion Criteria: * Acute intercurrent infection or complications * pregnancy or lactating patients * Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents. * Presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure
References
Publications (1)
- BACKGROUNDGbolahan OB, Porter RF, Salter JT, Yiannoutsos C, Burns M, Chiorean EG, Loehrer PJ Sr. A Phase II Study of Pemetrexed in Patients with Recurrent Thymoma and Thymic Carcinoma. J Thorac Oncol. 2018 Dec;13(12):1940-1948. doi: 10.1016/j.jtho.2018.07.094. Epub 2018 Aug 16. PMID 30121390