Paclitaxel and Cisplatin for Thymic Neoplasm

NCT ID: NCT00818090

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-11-30

Brief Summary

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

Conditions

Thymoma; Thymic Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TP

paclitaxel and cisplatin every 3 weeks

Group Type: EXPERIMENTAL

paclitaxel and cisplatin

Intervention Type: DRUG

paclitaxel and cisplatin every 3 weeks

Interventions

paclitaxel and cisplatin

paclitaxel and cisplatin every 3 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean Cancer Study Group

OTHER

Sponsor Role: lead

Responsible Party

Se-Hoon Lee

Korean Cancer Study Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dae Seog Heo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KCSG-LU08-03; CRCST-L-0003

Identifier Type: -

Identifier Source: org_study_id