Evaluation of BAY 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer Patients

NCT ID: NCT00044538

Last Updated: 2009-06-22

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

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2004-06-30

Brief Summary

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Lung cancer is among the most common cancers in the world and its incidence continues to increase. Chemotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) has been under investigation for several decades and several new drugs with activity in NSCLC have been identified. These include the taxanes, which are among the most commonly used class of chemotherapy agents in clinical oncology today. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY 59-8862 will be conducted to determine the anti-tumor efficacy of BAY 59-8862 in taxane-resistant 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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

BAY59-8862 (Cytotoxic Taxane)

Intervention Type DRUG

Intravenous dose over 60 minutes every 3 weeks

Interventions

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BAY59-8862 (Cytotoxic Taxane)

Intravenous dose over 60 minutes every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Measurable disease as defined by the presence of at least one measurable lesion
* Patients must have received at least 3 weeks of continuous therapy with Taxane - patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver and kidney function

Exclusion Criteria

* Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C; brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers
* excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant.
* others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Tucson, Arizona, United States

Site Status

Waterbury, Connecticut, United States

Site Status

Louisville, Kentucky, United States

Site Status

Metairie, Louisiana, United States

Site Status

Buffalo, New York, United States

Site Status

Columbus, Ohio, United States

Site Status

Nashville, Tennessee, United States

Site Status

Edmonton, Alberta, Canada

Site Status

Hamilton, Ontario, Canada

Site Status

Thunder Bay, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Québec, Quebec, Canada

Site Status

Gauting, Bavaria, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Kfar Saba, , Israel

Site Status

Tel Aviv, , Israel

Site Status

Tel Litwinsky, , Israel

Site Status

Modena, , Italy

Site Status

Parma, , Italy

Site Status

Pisa, , Italy

Site Status

Torino, , Italy

Site Status

Udine, , Italy

Site Status

Elche, Alicante, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barakaldo, Bizkaia, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Countries

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United States Canada Germany Israel Italy Spain

Other Identifiers

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10653

Identifier Type: -

Identifier Source: org_study_id

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