Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Phase II Trial of Single Agent ZD1839 (Iressa) in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
Because of the demonstrated single agent activity and excellent tolerability in patients with refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment of patients with advanced non-small cell lung cancer who have poor performance status. In this phase II trial, we will investigate the single agent activity of first-line ZD1839 in patients with advanced non-small cell lung cancer with poor performance status
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lung-cancer
Started Mar 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedMay 3, 2011
May 1, 2011
1 year
September 12, 2005
May 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
Secondary Outcomes (2)
Overall toxicity
Quality of life
Interventions
Eligibility Criteria
You may qualify if:
- To be included in this study, you must meet the following criteria:
- Biopsy proven non-small cell lung cancer
- Recurrent non-small cell lung cancer after previous surgery or radiation
- Advanced disease (stage IIIb or IV)
- No previous chemotherapy or biological therapy
- Require significant assistance with activities of daily living
- Measurable disease
- Adequate bone marrow, liver and kidney function
- Give written informed consent
You may not qualify if:
- You cannot participate in this study if any of the following apply to you:
- Brain metastasis
- Meningeal metastasis
- Other uncontrolled malignancies
- Women pregnant or lactating
- No measurable disease outside previous radiation therapy field
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- AstraZenecacollaborator
Related Publications (1)
Spigel DR, Hainsworth JD, Burkett ER, Burris HA, Yardley DA, Thomas M, Jones SF, Dickson NR, Scullin DC, Bradof JE, Rubinsak JR, Brierre JE, Greco FA. Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a Minnie Pearl Cancer Research Network Phase II Trial. Clin Lung Cancer. 2005 Sep;7(2):127-32. doi: 10.3816/CLC.2005.n.028.
PMID: 16179100RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
March 1, 2003
Primary Completion
March 1, 2004
Study Completion
September 1, 2005
Last Updated
May 3, 2011
Record last verified: 2011-05