Paclitaxel and Cisplatin for Thymic Neoplasm (NCT00818090) | Clinical Trial Compass
TerminatedPhase 2
Paclitaxel and Cisplatin for Thymic Neoplasm
Stopped: marginal statistical significance
South Korea39 participantsStarted 2008-09
Plain-language summary
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…