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Paclitaxel and Cisplatin for Thymic Neoplasm
This study is currently recruiting participants.
Verified by Korean Cancer Study Group, January 2009
Sponsored by: Korean Cancer Study Group
Information provided by: Korean Cancer Study Group
ClinicalTrials.gov Identifier: NCT00818090
  Purpose

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


Condition Intervention Phase
Thymoma
Thymic Carcinoma
Drug: paclitaxel and cisplatin
Phase II

MedlinePlus related topics: Cancer Thymus Cancer
Drug Information available for: Cisplatin Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma

Further study details as provided by Korean Cancer Study Group:

Primary Outcome Measures:
  • Response rate [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: start of medication to 4 weeks since the last medication ] [ Designated as safety issue: Yes ]
  • progression-free survival [ Time Frame: till progression ] [ Designated as safety issue: No ]
  • duration of response [ Time Frame: till progression ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: till death, last follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TP: Experimental
paclitaxel and cisplatin every 3 weeks
Drug: paclitaxel and cisplatin
paclitaxel and cisplatin every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818090

Contacts
Contact: Se-Hoon Lee, MD, PhD +82-2-2072-0832 shlee119@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Dae Seog Heo, MD, PhD            
Sub-Investigator: Se-Hoon Lee, MD, PhD            
Sub-Investigator: Dong Wan Kim, MD, PhD            
Sponsors and Collaborators
Korean Cancer Study Group
Investigators
Principal Investigator: Dae Seog Heo, MD, PhD Seoul National University
  More Information

Responsible Party: Seoul National University Hospital ( Dae Seog Heo )
Study ID Numbers: KCSG-LU08-03; CRCST-L-0003
Study First Received: January 5, 2009
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00818090  
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Cancer Study Group:
thymic epithelial tumor
paclitaxel
cisplatin
thymic carcinoma
invasive thymoma

Study placed in the following topic categories:
Thoracic Neoplasms
Cisplatin
Paclitaxel
Thymoma
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on January 16, 2009