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Paclitaxel and Cisplatin for Thymic Neoplasm

Primary Purpose

Thymoma, Thymic Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
paclitaxel and cisplatin
Sponsored by
Korean Cancer Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma focused on measuring thymic epithelial tumor, paclitaxel, cisplatin, thymic carcinoma, invasive thymoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TP

Arm Description

paclitaxel and cisplatin every 3 weeks

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

toxicity
progression-free survival
duration of response
overall survival

Full Information

First Posted
January 5, 2009
Last Updated
April 11, 2013
Sponsor
Korean Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00818090
Brief Title
Paclitaxel and Cisplatin for Thymic Neoplasm
Official Title
A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
marginal statistical significance
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Cancer Study Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma, Thymic Carcinoma
Keywords
thymic epithelial tumor, paclitaxel, cisplatin, thymic carcinoma, invasive thymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TP
Arm Type
Experimental
Arm Description
paclitaxel and cisplatin every 3 weeks
Intervention Type
Drug
Intervention Name(s)
paclitaxel and cisplatin
Intervention Description
paclitaxel and cisplatin every 3 weeks
Primary Outcome Measure Information:
Title
Response rate
Time Frame
6 weeks, 12 weeks, 18 weeks
Secondary Outcome Measure Information:
Title
toxicity
Time Frame
start of medication to 4 weeks since the last medication
Title
progression-free survival
Time Frame
till progression
Title
duration of response
Time Frame
till progression
Title
overall survival
Time Frame
till death, last follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Seog Heo, MD, PhD
Organizational Affiliation
Seoul National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Paclitaxel and Cisplatin for Thymic Neoplasm

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