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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. Identifier: NCT00818090
Recruitment Status : Terminated (marginal statistical significance)
First Posted : January 7, 2009
Last Update Posted : April 12, 2013
Information provided by (Responsible Party):
Se-Hoon Lee, Korean Cancer Study Group

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

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

Primary Outcome Measures :
  1. Response rate [ Time Frame: 6 weeks, 12 weeks, 18 weeks ]

Secondary Outcome Measures :
  1. toxicity [ Time Frame: start of medication to 4 weeks since the last medication ]
  2. progression-free survival [ Time Frame: till progression ]
  3. duration of response [ Time Frame: till progression ]
  4. overall survival [ Time Frame: till death, last follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00818090

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korean Cancer Study Group
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Principal Investigator: Dae Seog Heo, MD, PhD Seoul National University
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Responsible Party: Se-Hoon Lee, Korean Cancer Study Group Identifier: NCT00818090    
Other Study ID Numbers: KCSG-LU08-03; CRCST-L-0003
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: September 2012
Keywords provided by Se-Hoon Lee, Korean Cancer Study Group:
thymic epithelial tumor
thymic carcinoma
invasive thymoma
Additional relevant MeSH terms:
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Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action