Paclitaxel and Cisplatin for Thymic Neoplasm

NCT00818090 | Terminated Phase 2

• 1 other identifier: KCSG-LU08-03; CRCST-L-0003
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thymoma; Thymic Carcinoma

Keywords

thymic epithelial tumor; paclitaxel; cisplatin; thymic carcinoma; invasive thymoma

Outcome Measures

Primary Outcomes (1)

• Response rate

  6 weeks, 12 weeks, 18 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

TP

EXPERIMENTAL

paclitaxel and cisplatin every 3 weeks

Drug: paclitaxel and cisplatin

Interventions

paclitaxel and cisplatin DRUG

paclitaxel and cisplatin every 3 weeks

TP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Cancer Study Group: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Thymoma; Thymic epithelial tumor

Interventions

TP protocol

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dae Seog Heo, MD, PhD

  Seoul National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Korean Cancer Study Group

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 7, 2009
• Study Start: September 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 12, 2013

Record last verified: 2012-09

Locations

KR (1)