Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2005 |
End Date: | May 2012 |
To study the efficacy of Alimta as a single agent in thymic cancers
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.
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.
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
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