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

Patrick Joseph Loehrer Sr.

Status and phase

Completed

Phase 2

Conditions

Thymoma

Thymic Carcinoma

Treatments

Drug: Premetrexed (Alimta)

Study type

Interventional

Funder types

Other

Identifiers

NCT00198133

IUCRO-0088

0412-18 IUCRO-0088;

Details and patient eligibility

About

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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