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Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma

Phase 2
18 Years
Not Enrolling
Thymoma, Thymic Carcinoma

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Trial Information

Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma


- Determine the objective response rate in patients with advanced thymoma or thymic
carcinoma treated with carboplatin and paclitaxel.

- Determine the duration of response in these patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel by intravenous (IV) infusion 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 were 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 were to be accrued for this study within
3.8-4.6 years.

Inclusion Criteria:

- 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

- Age 18 and over

- ECOG Performance Status 0-1

- Granulocyte count at least 1,500 cells/mm^3

- Platelet count at least 100,000 cells/mm^3

- Bilirubin no greater than 1.5 mg/dL

- Creatinine no greater than 2.0 mg/dL

- Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed

Exclusion Criteria:

- Acute concurrent complications such as infection or post-surgical complications

- Other prior malignancy within the past 5 years unless curatively treated with no
evidence of recurrence

- Pregnant or nursing. A negative pregnancy test was required, and fertile patients
must use effective contraception

- Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant
chemotherapy allowed if disease-free survival prior to recurrence was more than 1

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response by RECIST Criteria (Version 1.0)

Outcome Description:

Number of eligible, treated participants in each response category by RECIST criteria

Outcome Time Frame:

Assessed every 2 cycles (6 weeks)

Safety Issue:


Principal Investigator

Patrick J. Loehrer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

August 2012

Related Keywords:

  • Thymoma
  • Thymic Carcinoma
  • thymoma
  • thymic carcinoma
  • Carcinoma
  • Thymoma



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