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A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma

Thank you

Trial Information

A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy


Inclusion Criteria:



- Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously
irradiated or non measurable disease

- Locally advanced or metastatic NSCLC, not amenable to curative surgery or
radiotherapy

- Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after
receiving prior treatment with platinum-based chemotherapy

- WHO performance status (PS) 0-2

- Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L

- Life expectancy of at least 8 weeks

Exclusion Criteria:

- Prior ZD1839 therapy

- Prior docetaxel treatment for NSCLC

- Less than 14 days since completion of prior radiotherapy

- Less than 21 days since prior chemotherapy, immunotherapy or biological systemic
anticancer therapy

- Evidence of clinically active Interstitial Lung Disease

- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ

- Newly diagnosed CNS metastases that have not yet been treated with surgery and/or
radiation. Patients with previously diagnosed and treated CNS metastases or spinal
cord compression may be considered if they have evidence of clinically SD (no steroid
therapy or steroid dose being tapered) for at least 28 days

- Patients with pre existing peripheral neuropathy >= grade 2 (NCI CTC criteria)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To compare overall survival between ZD1839 and docetaxel

Principal Investigator

AstraZeneca Iressa Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D791GC00001

NCT ID:

NCT00076388

Start Date:

February 2004

Completion Date:

October 2007

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Non-Small-Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research Site Alabaster, Alabama  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Lewes, Delaware  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Ashland, Kentucky  
Research Site Alexandria, Minnesota  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Bend, Oregon  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Abington, Virginia  
Research Site Auburn, Washington  
Research Site Appleton, Wisconsin