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Paclitaxel and Cisplatin for Thymic Neoplasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00818090
Recruitment Status : Terminated (marginal statistical significance)
First Posted : January 7, 2009
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Se-Hoon Lee, Korean Cancer Study Group

Tracking Information
First Submitted Date  ICMJE January 5, 2009
First Posted Date  ICMJE January 7, 2009
Last Update Posted Date April 12, 2013
Study Start Date  ICMJE September 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
Response rate [ Time Frame: 6 weeks, 12 weeks, 18 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
  • toxicity [ Time Frame: start of medication to 4 weeks since the last medication ]
  • progression-free survival [ Time Frame: till progression ]
  • duration of response [ Time Frame: till progression ]
  • overall survival [ Time Frame: till death, last follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paclitaxel and Cisplatin for Thymic Neoplasm
Official Title  ICMJE A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
Brief Summary To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thymoma
  • Thymic Carcinoma
Intervention  ICMJE Drug: paclitaxel and cisplatin
paclitaxel and cisplatin every 3 weeks
Study Arms  ICMJE Experimental: TP
paclitaxel and cisplatin every 3 weeks
Intervention: Drug: paclitaxel and cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 26, 2012)
39
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2009)
50
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818090
Other Study ID Numbers  ICMJE KCSG-LU08-03; CRCST-L-0003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Se-Hoon Lee, Korean Cancer Study Group
Study Sponsor  ICMJE Korean Cancer Study Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dae Seog Heo, MD, PhD Seoul National University
PRS Account Korean Cancer Study Group
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP