Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Carboplatin Combined with Paclitaxel in Treating Patients With Advanced Thymoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	ECOG-1C99 NCI-E1C99, E1C99, NCT00010257

Objectives

1. Determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel.
2. Determine the duration of response in these patients treated with this regimen.
3. Determine the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery
  • Extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy)
  • Advanced limited disease allowed if ineligible for primary radiotherapy or surgery



• Measurable disease

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for metastatic disease
• Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year

Endocrine therapy:

• Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed

Radiotherapy:

• See Disease Characteristics
• No concurrent local radiotherapy for pain control or life threatening situations

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500 cells/mm³
• Platelet count at least 100,000 cells/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• No acute concurrent complications such as infection or post-surgical complications
• No other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 35-68 patients will be accrued for this study within 3.8-4.6 years.

Outcomes

Objective response rate

Duration of response
Toxicity

Outline

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression. Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further treatment may be given at the discretion of the treating physician.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

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

Patrick Loehrer, MD, Protocol chair		Ph: 317-278-7418; 888-600-4822

Registry Information
Official Title		Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma
Trial Start Date		2001-02-21
Trial Completion Date		2008-11-06
Registered in ClinicalTrials.gov		NCT00010257
Date Submitted to PDQ		2001-01-02
Information Last Verified		2008-10-24
NCI Grant/Contract Number		CA21115