Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

Study Overview
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Brief Summary
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To study the efficacy of Alimta as a single agent in thymic cancers

Detailed Description
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The broad range of clinical activity of thymic carcinomas makes the likelihood of detecting efficacy of a single agent such as premetrexed a reasonable objective since these malignancies are relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.

Official Title
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Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

Conditions
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Thymoma, Thymic Carcinoma

Intervention / Treatment
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* Drug: Premetrexed (Alimta)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed<br>Pemetrexed infusion once every 21 days (one cycle). | Drug: Premetrexed (Alimta)<br>* Pemetrexed will be 500 mg/m2 IV every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (Complete and Partial Response) | 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. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Remission | Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis. | Time from the date of remission until progression or death, assessed up to 3 years | 
| Grade 3/4 Treatment Related Adverse Events | To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely). | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thymoma, Thymic Carcinoma