Paclitaxel and Cisplatin for Thymic Neoplasm

National Cancer Center (NCC)

Status and phase: Terminated; Phase 2

Conditions: Thymoma; Thymic Carcinoma

Treatments: Drug: paclitaxel and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00818090

KCSG-LU08-03 CRCST-L-0003;

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

TP

Experimental group

Description:

paclitaxel and cisplatin every 3 weeks

Treatment:

Drug: paclitaxel and cisplatin