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CompletedNCT00139711Updated Apr 1, 2008

Three Combinations Of Docetaxel And Irinotecan For Recurrent Or Metastatic Non Small Cell Lung Cancer

A Phase 2 interventional study of Irinotecan and Docetaxel in Carcinoma, Non-Small-Cell Lung, sponsored by Pfizer. Completed at 15 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-04-01.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 138 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically proven NSCLC
  • Recurrent or metastatic NCSLC

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
138 participants

Interventions

  • DrugIrinotecan
  • DrugDocetaxel
06

What researchers measure

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

07

Study locations

15 sites
  • 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
    Milano, 20133, Italy
  • Pfizer Investigational Site
    Monza, 20052, Italy
  • Pfizer Investigational Site
    Napoli, 80136, Italy
  • Pfizer Investigational Site
    Varses, 21100, Italy
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00139711
Lead sponsor
Pfizer
First posted
Aug 31, 2005
Start date
Mar 2003
Completion
Jun 2006
Last update
Apr 1, 2008

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

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