Paclitaxel and Cisplatin for Thymic Neoplasm

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

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

Study Overview

• Status: Terminated
• Conditions: Thymic Carcinoma; Thymoma
• Intervention / Treatment: Drug: paclitaxel and cisplatin

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TP; paclitaxel and cisplatin every 3 weeks	Drug: paclitaxel and cisplatin; paclitaxel and cisplatin every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate	6 weeks, 12 weeks, 18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
toxicity	start of medication to 4 weeks since the last medication
progression-free survival	till progression
duration of response	till progression
overall survival	till death, last follow-up

Collaborators and Investigators

• Sponsor: Korean Cancer Study Group
• Investigators: Principal Investigator: Dae Seog Heo, MD, PhD, Seoul National University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: January 5, 2009
• First Submitted That Met QC Criteria: January 6, 2009
• First Posted (Estimate): January 7, 2009

Study Record Updates

• Last Update Posted (Estimate): April 12, 2013
• Last Update Submitted That Met QC Criteria: April 11, 2013
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: cisplatin; paclitaxel; thymic carcinoma; thymic epithelial tumor; invasive thymoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Thoracic Neoplasms; Neoplasms, Complex and Mixed; Carcinoma; Thymoma; Thymus Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: KCSG-LU08-03; CRCST-L-0003