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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 SiteAlabaster, Alabama  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteLewes, Delaware  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteAshland, Kentucky  
Research SiteAlexandria, Minnesota  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin