Trial Condition(s):

Carcinoma, Non-Small-Cell Lung

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

Bayer Identifier:

10653

ClinicalTrials.gov Identifier:

NCT00044538

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
102
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Cytotoxic Taxane (BAY59-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Sapir Medical Center, Meir General Hospital

Kfar Saba, Israel, 44281

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

Jayne Gurtler APMC

Metairie, United States, 70006

Status
Completed
 
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

Status
Completed
 
Locations

Norton Healthcare Pavilion

Louisville, United States, 40202

Status
Completed
 
Locations

Hospital Ramón y Cajal

Madrid, Spain, 28034

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

A.O.U. S.G.Battista-Molinette

Torino, Italy, 10126

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Arizona Clinical Research Center

Tucson, United States, 85712

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41100

Status
Completed
 
Locations

Roswell Park Cancer Institute

Buffalo, United States, 14263-0001

Status
Completed
 
Locations

Harold Leever Cancer Center

Waterbury, United States, 06708-2904

Status
Completed
 
Locations

Juravinski Cancer Centre

Hamilton, Canada, L8V 5C2

Status
Completed
 
Locations

Asklepios Fachkliniken München Gauting

Gauting, Germany, 82131

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Hopital Laval

Quebec, Canada, G1V 4G5

Status
Completed
 
Locations

Hospital General de Elche

Elche, Spain, 03203

Status
Completed
 
Locations

Northwestern Ontario Regional Cancer Centre

Thunder Bay, Canada, P7A 7T1

Status
Completed
 
Locations

Tennessee Oncology, PC

Nashville, United States, 37205

Status
Completed
 
Locations

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Hospital de Cruces

Barakaldo, Spain, 48903

Status
Completed
 
Locations

Hematology Oncology Consultants, Inc.

Columbus, United States, 43235

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

A.O.U. di Parma

Parma, Italy, 43100

Status
Completed
 

For details, please refer to trial results

Additional Information