Paclitaxel and Cisplatin for Thymic Neoplasm

Study Overview
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Brief Summary
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To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma

Official Title
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A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma

Conditions
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Thymoma, Thymic Carcinoma

Intervention / Treatment
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* Drug: paclitaxel and cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically or cytologically confirmed invasive thymoma or thymic carcinoma unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator) no previous systemic treatment for invasive thymoma or thymic carcinoma at least one measurable lesion by RECIST criteria 18 years old or older ECOG performance status 0, 1, 2 adequate lab. findings neutrophil ≥ 1.5 x 10^9/L platelet ≥ 75 x 10^9/L hemoglobin ≥ 9.0 g/dL bilirubin ≤ 1.5 x upper normal limit AST, ALT ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine > 1.0 x upper normal limit, creatinine clearance ≥ 60 mL/min patient who agree to written, informed consent Exclusion Criteria: other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection) active bacterial infection history of clinical trial with investigational drug within 30 days radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted) pregnant, or lactating women patient with organ transplantation peripheral neuropathy, grade 2 or greater severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TP<br>paclitaxel and cisplatin every 3 weeks | Drug: paclitaxel and cisplatin<br>* paclitaxel and cisplatin every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 6 weeks, 12 weeks, 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  | start of medication to 4 weeks since the last medication | 
| progression-free survival |  | till progression | 
| duration of response |  | till progression | 
| overall survival |  | till death, last follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thymic epithelial tumor, paclitaxel, cisplatin, thymic carcinoma, invasive thymoma