Paclitaxel and Cisplatin for Thymic Neoplasm

This study has been terminated.
(marginal statistical significance)
Sponsor:
Information provided by (Responsible Party):
Se-Hoon Lee, Korean Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00818090
First received: January 5, 2009
Last updated: April 11, 2013
Last verified: September 2012
  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 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818090

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

No publications provided

Responsible Party: Se-Hoon Lee, Korean Cancer Study Group
ClinicalTrials.gov 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
paclitaxel
cisplatin
thymic carcinoma
invasive thymoma

Additional relevant MeSH terms:
Carcinoma
Thymoma
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014