Paclitaxel and Cisplatin for Thymic Neoplasm

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korean Cancer Study Group
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

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