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Study for Patients With Non Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00168883

Last Updated: 2006-11-01

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-12-31

Brief Summary

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This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

Detailed Description

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Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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NSCLC curative non-treatable NSCLC UICC stage IIIB and IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Carboplatin

Intervention Type DRUG

Paclitaxel

Intervention Type DRUG

Vinorelbine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV

Exclusion Criteria

* New York Heart Association (NYHA) III or IV
* Brain metastases
* Neurotoxicity Grade 2 or greater
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Pierre Fabre Pharma GmbH

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Principal Investigators

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Ulrich Keilholz, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Hematology & Oncology Charité CBF Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ulrich Keilholz, MD

Role: CONTACT

Phone: +49-30-8445-3596

Email: [email protected]

Alexander Schmittel, MD

Role: CONTACT

Phone: +49-30-8445-3090

Email: [email protected]

Facility Contacts

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Ulrich Keilholz, MD

Role: primary

Alexander Schmittel, MD

Role: backup

Other Identifiers

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Haema CBF NSCLC UK/AS 03

Identifier Type: -

Identifier Source: org_study_id