Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients
A Randomized Phase III Comparison of Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Elderly or Poor Performance Status Patients With Advanced Non-Small Cell Lung Cancer
2 other identifiers
interventional
346
1 country
1
Brief Summary
In this randomized trial, we attempt to further define optimal palliative chemotherapy for elderly patients with advanced non-small cell lung cancer by comparing single agent treatment with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lung-cancer
Started Aug 2001
Longer than P75 for phase_2 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJune 28, 2010
January 1, 2009
4.8 years
September 12, 2005
June 24, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
median survival
one-year survival.
Secondary Outcomes (1)
toxicity
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
- No previous chemotherapy.
- Age \> 65 years
- Age \< 65 years requires significant assistance to perform activities of daily
- Stage IV disease or stage IIIB disease
- Ability to perform activities of daily living with minimal assistance
- Measurable or evaluable disease
- Adequate bone marrow, liver and kidney
- All patients must sign written informed consent prior to study entry.
You may not qualify if:
- You cannot participate in this study if any of the following apply to you:
- Brain metastases
- Meningeal metastases
- Other uncontrolled malignancies
- History of invasive cancer during the last 5 years
- Moderate to severe peripheral neuropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Aventis Pharmaceuticalscollaborator
Study Sites (1)
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related Publications (1)
Hainsworth JD, Spigel DR, Farley C, Shipley DL, Bearden JD, Gandhi J, Ann Houston G, Anthony Greco F. Weekly docetaxel versus docetaxel/gemcitabine in the treatment of elderly or poor performance status patients with advanced nonsmall cell lung cancer: a randomized phase 3 trial of the Minnie Pearl Cancer Research Network. Cancer. 2007 Nov 1;110(9):2027-34. doi: 10.1002/cncr.23019.
PMID: 17823908RESULT
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
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
August 1, 2001
Primary Completion
May 1, 2006
Study Completion
January 1, 2009
Last Updated
June 28, 2010
Record last verified: 2009-01