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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2012-05-31

Brief Summary

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To study the efficacy of Alimta as a single agent in thymic cancers

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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.

Conditions

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Thymoma Thymic Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pemetrexed

Pemetrexed infusion once every 21 days (one cycle).

Group Type EXPERIMENTAL

Premetrexed (Alimta)

Intervention Type DRUG

Pemetrexed will be 500 mg/m2 IV every 3 weeks

Interventions

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Premetrexed (Alimta)

Pemetrexed will be 500 mg/m2 IV every 3 weeks

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No