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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00010257 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
| Condition | Intervention | Phase |
|
Thymoma and Thymic Carcinoma |
Drug: carboplatin Drug: paclitaxel |
Phase II |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Carboplatin Paclitaxel |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma |
| Estimated Enrollment: | 68 |
| Study Start Date: | February 2001 |
| Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 35-68 patients will be accrued for this study within 3.8-4.6 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations![]() |
Show 67 Study Locations |
| Eastern Cooperative Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Patrick J. Loehrer, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
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.
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| Study ID Numbers: | CDR0000068461, ECOG-1C99, NCI-E1C99 |
| First Received: | February 2, 2001 |
| Last Updated: | October 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00010257 |
| Health Authority: | United States: Federal Government |
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