Thymoma Clinical Trial
Official title:
A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
Verified date | September 2012 |
Source | Korean Cancer Study Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Status | Terminated |
Enrollment | 39 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korean Cancer Study Group |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | 6 weeks, 12 weeks, 18 weeks | No | |
Secondary | toxicity | start of medication to 4 weeks since the last medication | Yes | |
Secondary | progression-free survival | till progression | No | |
Secondary | duration of response | till progression | No | |
Secondary | overall survival | till death, last follow-up | No |
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