Paclitaxel and Cisplatin for Thymic Neoplasm

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

Tracking Information

• First Submitted Date: January 5, 2009
• First Posted Date: January 7, 2009
• Last Update Posted Date: April 12, 2013
• Study Start Date: September 2008
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 6, 2009): Response rate [ Time Frame: 6 weeks, 12 weeks, 18 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Paclitaxel and Cisplatin for Thymic Neoplasm
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Thymoma
• Thymic Carcinoma

Intervention

Drug: paclitaxel and cisplatin

paclitaxel and cisplatin every 3 weeks

Study Arms

Experimental: TP

paclitaxel and cisplatin every 3 weeks

Intervention: Drug: paclitaxel and cisplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 26, 2012): 39
• Original Estimated Enrollment (submitted: January 6, 2009): 50
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00818090
• Other Study ID Numbers: KCSG-LU08-03; CRCST-L-0003
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Se-Hoon Lee, Korean Cancer Study Group
• Study Sponsor: Korean Cancer Study Group
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dae Seog Heo, MD, PhD; Seoul National University

• PRS Account: Korean Cancer Study Group
• Verification Date: September 2012