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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00139711
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : April 1, 2008
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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)

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Irinotecan Drug: Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2003
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  1. Evaluate, in each arm, the time to progression, the duration of response and the survival

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically proven NSCLC
  • Recurrent or metastatic NCSLC

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00139711

Pfizer Investigational Site
Alzano Lombardo, BG, Italy, 24022
Pfizer Investigational Site
Gravedona, CO, Italy, 22015
Pfizer Investigational Site
Crema, CR, Italy, 26013
Pfizer Investigational Site
Gorgonzola, MI, Italy, 20064
Pfizer Investigational Site
Melegnano, MI, Italy, 20070
Pfizer Investigational Site
Vimercate, MI, Italy, 20059
Pfizer Investigational Site
Bari, Italy, 70126
Pfizer Investigational Site
Benevento, Italy, 82100
Pfizer Investigational Site
Borgomanero, Italy, 28021
Pfizer Investigational Site
Brescia, Italy, 25123
Pfizer Investigational Site
Mantova, Italy, 46100
Pfizer Investigational Site
Milano, Italy, 20133
Pfizer Investigational Site
Monza, Italy, 20052
Pfizer Investigational Site
Napoli, Italy, 80136
Pfizer Investigational Site
Varses, Italy, 21100
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information: Identifier: NCT00139711     History of Changes
Other Study ID Numbers: XRP6976C/2501
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: October 2006

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors