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OpenTrials
Completed

NCT Number: NCT00139711

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 (NSCLC)

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Alzano Lombardo, BG, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irinotecan

Drug

docetaxel

Drug

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2003
Study completion
2006
First posted
Aug 31, 2005
Registry last updated
Apr 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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