Three Combinations Of Docetaxel And Irinotecan For Recurrent Or Metastatic Non Small Cell Lung Cancer
A Multicenter Randomized Phase II Study Evaluating The Activity And Tolerability Of Three Different Combinations Of Docetaxel (Taxotere) And Irinotecan (Campto) As Second Line Therapy For Recurrent Or Metastatic Non Small Cell Lung Cancer (NSCLS)
2 other identifiers
interventional
138
1 country
15
Brief Summary
A multicenter randomized phase II study evaluating the activity and tolerability of three different combinations of docetaxel (taxotere) and irinotecan (campto) as second line therapy for recurrent or metastatic non small cell lung cancer (NSCLC)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2003
Typical duration for phase_2
15 active sites
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
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 31, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedApril 1, 2008
October 1, 2006
August 29, 2005
March 27, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the activity and tolerability of the association of irinotecan and docetaxel according to three different schedules as second line treatment for recurrent or metastatic NSCLC.
Secondary Outcomes (1)
Evaluate, in each arm, the time to progression, the duration of response and the survival
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically proven NSCLC
- Recurrent or metastatic NCSLC
You may not qualify if:
- Prior malignancies; except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer adequately treated an with non evidence of disease for at least 5 years
- History or presence of brain or meningeal metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (15)
Pfizer Investigational Site
Alzano Lombardo, BG, 24022, Italy
Pfizer Investigational Site
Gravedona, CO, 22015, Italy
Pfizer Investigational Site
Crema, CR, 26013, Italy
Pfizer Investigational Site
Gorgonzola, MI, 20064, Italy
Pfizer Investigational Site
Melegnano, MI, 20070, Italy
Pfizer Investigational Site
Vimercate, MI, 20059, Italy
Pfizer Investigational Site
Bari, 70126, Italy
Pfizer Investigational Site
Benevento, 82100, Italy
Pfizer Investigational Site
Borgomanero, 28021, Italy
Pfizer Investigational Site
Brescia, 25123, Italy
Pfizer Investigational Site
Mantova, 46100, Italy
Pfizer Investigational Site
Milan, 20133, Italy
Pfizer Investigational Site
Monza, 20052, Italy
Pfizer Investigational Site
Napoli, 80136, Italy
Pfizer Investigational Site
Varses, 21100, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 31, 2005
Study Start
March 1, 2003
Study Completion
June 1, 2006
Last Updated
April 1, 2008
Record last verified: 2006-10