Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

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

Conditions
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Thymoma, Thymic Carcinoma

Intervention / Treatment
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* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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 year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel plus Carboplatin<br>Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle | Drug: carboplatin<br>* Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles<br>* Other names: NSC # 241240;Drug: paclitaxel<br>* 225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles<br>* Other names: NSC #125973;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response by RECIST Criteria (Version 1.0) | Number of eligible, treated participants in each response category by RECIST criteria | Assessed every 2 cycles (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria | assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thymoma, thymic carcinoma