Status:
TERMINATED
Paclitaxel and Cisplatin for Thymic Neoplasm
Lead Sponsor:
Korean Cancer Study Group
Conditions:
Thymoma
Thymic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00818090
Start Date
September 1 2008
End Date
November 1 2011
Last Update
April 12 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea