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

NCT ID: NCT00139711

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Irinotecan

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Alzano Lombardo, BG, Italy

Site Status

Pfizer Investigational Site

Gravedona, CO, Italy

Site Status

Pfizer Investigational Site

Crema, CR, Italy

Site Status

Pfizer Investigational Site

Gorgonzola, MI, Italy

Site Status

Pfizer Investigational Site

Melegnano, MI, Italy

Site Status

Pfizer Investigational Site

Vimercate, MI, Italy

Site Status

Pfizer Investigational Site

Bari, , Italy

Site Status

Pfizer Investigational Site

Benevento, , Italy

Site Status

Pfizer Investigational Site

Borgomanero, , Italy

Site Status

Pfizer Investigational Site

Brescia, , Italy

Site Status

Pfizer Investigational Site

Mantova, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Monza, , Italy

Site Status

Pfizer Investigational Site

Napoli, , Italy

Site Status

Pfizer Investigational Site

Varses, , Italy

Site Status

Countries

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Italy

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=XRP6976C/2501&StudyName=Three+Combinations+Of+Docetaxel+And+Irinotecan+For+Recurrent+Or+Metastatic+Non+Small+Cell+Lung+Cancer+

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5961088

Identifier Type: -

Identifier Source: secondary_id

XRP6976C/2501

Identifier Type: -

Identifier Source: org_study_id