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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Patrick Joseph Loehrer Sr.
• Treatments: Pemetrexed

Criteria

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/=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