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

Phase 2
18 Years
Open (Enrolling)
Thymoma, Thymic Carcinoma

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to determine the objective response rate of premetrexed in previously treated patients with thymoma or thymic carcinoma.

Outcome Time Frame:

baseline, after 2 cycles, then q 6wks

Safety Issue:


Principal Investigator

Patrick Loehrer, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University


United States: Institutional Review Board

Study ID:

0412-18; IUCRO-0088



Start Date:

January 2005

Completion Date:

July 2013

Related Keywords:

  • Thymoma
  • Thymic Carcinoma
  • Thymoma
  • Thymic Carcinoma
  • Carcinoma
  • Thymoma



Indiana University Cancer Center Indianapolis, Indiana  46202-5265