Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	no age specified	NCI	EST-2582

Objectives

I.  Determine the efficacy of cis-platinum in the treatment of recurrent and 
metastatic invasive thymoma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with biopsy-proven 
metastatic or recurrent invasive thymoma that is considered inoperable and/or 
not amenable to radiotherapy.  Disease must be measurable (previously 
irradiated lesions are acceptable provided that clear progression has occurred 
following irradiation).  Patients must have an ECOG performance score of 0, 1, 
2, or 3 and adequate blood counts and renal and hepatic function.  No 
chemotherapy or radiotherapy is allowed during the 4 weeks prior to entry, and 
patients must have recovered from the side effects of any prior therapy.  
There may have been no prior therapy with cis-platinum and no concurrent 
glucocorticoids.

Expected Enrollment

25 patients will be required.  It is estimated that 5 patients per year will 
be accrued.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  cis-Platinum, CACP, NSC-119875.

Bonomi PD, Finkelstein D, Aisner S, et al.: EST 2582 phase II trial of cisplatin in metastatic or recurrent thymoma. Am J Clin Oncol 16 (4): 342-5, 1993.[PUBMED Abstract]

Loehrer PJ, Wang W, Aisner S, et al.: Long-term follow-up of patients with locally advanced or metastatic thymic malignancies: the Eastern Cooperative Oncology Group (ECOG) experience. [Abstract] J Clin Oncol 22 (Suppl 14): A-7050, 629s, 2004.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Philip Bonomi, MD, Protocol chair		Ph: 312-942-8312 Email: Philip_Bonomi@rsh.net