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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139711
First received: August 29, 2005
Last updated: March 27, 2008
Last verified: October 2006
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139711

Locations
Italy
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00139711     History of Changes
Other Study ID Numbers: XRP6976C/2501, A5961088
Study First Received: August 29, 2005
Last Updated: March 27, 2008
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Irinotecan
Docetaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 18, 2014