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

June 19, 2009 updated by: Bayer

An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
      • Thunder Bay, Ontario, Canada, P7A 7T1
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • Germany
      • Berlin, Germany, 13353
    • Bayern
      • Gauting, Bayern, Germany, 82131
  • Israel
      • Kfar Saba, Israel, 44281
      • Tel Aviv, Israel, 64239
      • Tel Hashomer, Israel, 52621
  • Italy
      • Modena, Italy, 41100
      • Parma, Italy, 43100
      • Pisa, Italy, 56126
      • Torino, Italy, 10126
      • Udine, Italy, 33100
  • Spain
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28040
      • Madrid, Spain, 28034
    • Alicante
      • Elche, Alicante, Spain, 03203
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
    • Connecticut
      • Waterbury, Connecticut, United States, 06708-2904
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • New York
      • Buffalo, New York, United States, 14263-0001
    • Ohio
      • Columbus, Ohio, United States, 43235
    • Tennessee
      • Nashville, Tennessee, United States, 37205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: BAY59-8862 (Cytotoxic Taxane)
Intravenous dose over 60 minutes every 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

August 30, 2002

First Submitted That Met QC Criteria

September 3, 2002

First Posted (Estimate)

September 4, 2002

Study Record Updates

Last Update Posted (Estimate)

June 22, 2009

Last Update Submitted That Met QC Criteria

June 19, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10653

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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