Paclitaxel and Cisplatin for Thymic Neoplasm

Sponsor

Korean Cancer Study Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00818090

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Thymoma Thymic Carcinoma	Drug: paclitaxel and cisplatin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TP paclitaxel and cisplatin every 3 weeks	Drug: paclitaxel and cisplatin paclitaxel and cisplatin every 3 weeks

Arm

Intervention/Treatment

Experimental: TP

paclitaxel and cisplatin every 3 weeks

Drug: paclitaxel and cisplatin

paclitaxel and cisplatin every 3 weeks

Outcome Measures

Primary Outcome Measures

Response rate [6 weeks, 12 weeks, 18 weeks]

Secondary Outcome Measures

toxicity [start of medication to 4 weeks since the last medication]
progression-free survival [till progression]
duration of response [till progression]
overall survival [till death, last follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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