Paclitaxel and Cisplatin for Thymic Neoplasm

This study has been terminated.
(marginal statistical significance)
Information provided by (Responsible Party):
Se-Hoon Lee, Korean Cancer Study Group Identifier:
First received: January 5, 2009
Last updated: April 11, 2013
Last verified: September 2012
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma

Condition Intervention Phase
Thymic Carcinoma
Drug: paclitaxel and cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma

Resource links provided by NLM:

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 ]

Enrollment: 39
Study Start Date: September 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TP
paclitaxel and cisplatin every 3 weeks
Drug: paclitaxel and cisplatin
paclitaxel and cisplatin every 3 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00818090

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korean Cancer Study Group
Principal Investigator: Dae Seog Heo, MD, PhD Seoul National University
  More Information

Responsible Party: Se-Hoon Lee, Korean Cancer Study Group Identifier: NCT00818090     History of Changes
Other Study ID Numbers: KCSG-LU08-03; CRCST-L-0003 
Study First Received: January 5, 2009
Last Updated: April 11, 2013
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Thymus Neoplasms
Lymphatic Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Thoracic Neoplasms
Albumin-Bound Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators processed this record on May 26, 2016