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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 29, 2005
Last updated: March 27, 2008
Last verified: October 2006
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 Intervention Phase
Carcinoma, Non-Small-Cell Lung Drug: Irinotecan Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

Estimated Enrollment: 138
Study Start Date: March 2003
Estimated Study Completion Date: June 2006

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Additional Information: Identifier: NCT00139711     History of Changes
Other Study ID Numbers: XRP6976C/2501
Study First Received: August 29, 2005
Last Updated: March 27, 2008

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 processed this record on August 17, 2017