Paclitaxel and Cisplatin for Thymic Neoplasm

Thymoma Clinical Trial

Official title:

A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00818090
• Other study ID #: KCSG-LU08-03; CRCST-L-0003
• Status: Terminated
• Phase: Phase 2
• First received: January 5, 2009
• Last updated: April 11, 2013
• Start date: September 2008
• Est. completion date: November 2011

Study information

• Verified date: September 2012
• Source: Korean Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Thymic Carcinoma
• Thymoma
• Thymus Neoplasms

Intervention

Drug:
• paclitaxel and cisplatin
paclitaxel and cisplatin every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		6 weeks, 12 weeks, 18 weeks	No
Secondary	toxicity		start of medication to 4 weeks since the last medication	Yes
Secondary	progression-free survival		till progression	No
Secondary	duration of response		till progression	No
Secondary	overall survival		till death, last follow-up	No