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


Phase 2
18 Years
N/A
Not Enrolling
Both
Thymoma, Thymic Carcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

6 weeks, 12 weeks, 18 weeks

Safety Issue:

No

Principal Investigator

Dae Seog Heo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University

Authority:

Korea: Food and Drug Administration

Study ID:

KCSG-LU08-03; CRCST-L-0003

NCT ID:

NCT00818090

Start Date:

September 2008

Completion Date:

November 2011

Related Keywords:

  • Thymoma
  • Thymic Carcinoma
  • thymic epithelial tumor
  • paclitaxel
  • cisplatin
  • thymic carcinoma
  • invasive thymoma
  • Carcinoma
  • Thymoma
  • Thymus Neoplasms

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