Status:
COMPLETED
Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Lead Sponsor:
Patrick Joseph Loehrer Sr.
Conditions:
Thymoma
Thymic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To study the efficacy of Alimta as a single agent in thymic cancers
Detailed Description
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 relativel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00198133
Start Date
January 1 2005
End Date
May 1 2012
Last Update
July 22 2019
Active Locations (1)
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1
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202