This trial is active, not recruiting.

Conditions thymoma, thymic carcinoma
Treatment premetrexed (alimta)
Phase phase 2
Sponsor Patrick Joseph Loehrer Sr.
Start date January 2005
End date December 2006
Trial size 27 participants
Trial identifier NCT00198133, 0412-18; IUCRO-0088, IUCRO-0088


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Pemetrexed infusion once every 21 days (one cycle).
premetrexed (alimta)
Pemetrexed will be 500 mg/m2 IV every 3 weeks

Primary Outcomes

to determine the objective response rate of premetrexed in previously treated patients with thymoma or thymic carcinoma.
time frame: baseline, after 2 cycles, then q 6wks

Secondary Outcomes

To determine the duration of remission of patients with thymoma and thymic carcinoma treated with premetrexed. To determine the toxicity of premetrexed in this patient population.
time frame: baseline, after 2 cycles, then q 6wks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Principal investigator Patrick Loehrer, M.D.
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 relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Indiana University.