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Completed

NCT Number: NCT00242801

Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • · Life expectancy of at least 8 weeks.
  • Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
  • Not suitable for chemotherapy
  • WHO Performance status 0,1, 2 or 3

Exclusion criteria

  • Newly diagnosed CNS mets
  • Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
  • ALT/AST greater than 5 x upper limit of normal
  • ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Treatment and study plan

Gefitinib

Drug

Primary outcomes

  1. The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care

Secondary outcomes

  1. · ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure

  2. · ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall

  3. · objective tumour response (CR + PR)

  4. · ZD1839 + BSC versus Placebo + BSC in terms of tolerability

  5. · ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen

Important dates

Study start
2003
Study completion
2005
First posted
Oct 21, 2005
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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