NCT00044538

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2001

Geographic Reach
6 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

First QC Date

August 30, 2002

Last Update Submit

June 19, 2009

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

TaxaneLung cancer, non-small cellNSCLC

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: BAY59-8862 (Cytotoxic Taxane)

Interventions

BAY59-8862 (Cytotoxic Taxane)DRUG

Intravenous dose over 60 minutes every 3 weeks

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Unknown Facility

Tucson, Arizona, 85712, United States

Location

Unknown Facility

Waterbury, Connecticut, 06708-2904, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

Buffalo, New York, 14263-0001, United States

Location

Unknown Facility

Columbus, Ohio, 43235, United States

Location

Unknown Facility

Nashville, Tennessee, 37205, United States

Location

Unknown Facility

Edmonton, Alberta, T6G 1Z2, Canada

Location

Unknown Facility

Hamilton, Ontario, L8V 5C2, Canada

Location

Unknown Facility

Thunder Bay, Ontario, P7A 7T1, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1E2, Canada

Location

Unknown Facility

Québec, Quebec, G1V 4G5, Canada

Location

Unknown Facility

Gauting, Bavaria, 82131, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Kfar Saba, 44281, Israel

Location

Unknown Facility

Tel Aviv, 64239, Israel

Location

Unknown Facility

Tel Litwinsky, 52621, Israel

Location

Unknown Facility

Modena, 41100, Italy

Location

Unknown Facility

Parma, 43100, Italy

Location

Unknown Facility

Pisa, 56126, Italy

Location

Unknown Facility

Torino, 10126, Italy

Location

Unknown Facility

Udine, 33100, Italy

Location

Unknown Facility

Elche, Alicante, 03203, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08036, Spain

Location

Unknown Facility

Barakaldo, Bizkaia, 48903, Spain

Location

Unknown Facility

Madrid, Madrid, 28034, Spain

Location

Unknown Facility

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

IDN 5109

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2002

First Posted

September 4, 2002

Study Start

December 1, 2001

Study Completion

June 1, 2004

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

CA(5)ES(5)IT(5)DE(2)IL(3)US(7)