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A Randomized/Open Label/Parallel Group/Multicenter/Phase IV Study to Assess Safety/Tolerability/Efficacy of Oral Gefitinib 250 mg Versus IV Docetaxel 60 mg/m2 in Patients With Locally Advanced or Metastatic NSCL Cancer of Adenocarcinoma Histology Previous Treated With One Platinum Base Chemotherapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Randomized/Open Label/Parallel Group/Multicenter/Phase IV Study to Assess Safety/Tolerability/Efficacy of Oral Gefitinib 250 mg Versus IV Docetaxel 60 mg/m2 in Patients With Locally Advanced or Metastatic NSCL Cancer of Adenocarcinoma Histology Previous Treated With One Platinum Base Chemotherapy


Inclusion Criteria:



- Locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC, not amenable to
curative surgery or radiotherapy

- Treatment with one prior chemotherapy regimen, which must have been platinum based*

*Patients must have demonstrated radiological or clinical
progression since completion of previous chemotherapy regimen.

- Adequate hepatic function, defined as BOTH a bilirubin < upper limit of reference
range (ULRR) AND an "Eligible" combination of transaminases (aspartate
aminotransferase (AST) or alanine aminotransferase (ALT)) and alkaline phosphatase
(ALP) below: Not Eligible: AST or ALT > 5xULRR, 1.5xULRR < AST or ALT < 5xULRR and
ALP> ULRR, 1xULRR < AST or ALT < 1.5xULRR and ALP> 2.5xULRR, AST or ALT <= ULRR and
ALP> 5xULRR For more information please refer to TAXOTERE® (docetaxel) prescribing
information

Exclusion Criteria:

- Prior therapy with gefitinib or other EGFR TK inhibitors (HER-1 receptor
inhibitors/small molecule or monoclonal antibody therapy)

- Prior docetaxel treatment for NSCLC

- Patients with pre-existing peripheral neuropathy ┬│ grade 2 (NCI CTCAE criteria)

- Past medical history of interstitial lung disease, drug induced interstitial
disease, radiation pneumonitis that required steroid treatment or any evidence
of clinically active interstitial lung disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to compare safety and tolerability between gefitinib and docetaxel

Outcome Time Frame:

time to disease progression

Safety Issue:

No

Principal Investigator

Han-Pin Kuo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director of Chest Department, Chang Gung Memorial Hospital, Linkou

Authority:

Taiwan: Department of Health

Study ID:

D7913C00046

NCT ID:

NCT00536107

Start Date:

October 2007

Completion Date:

August 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Cancer
  • Locally Advanced or Metastatic NSCL Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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