check_circleStudy Completed

Carcinoma, Non-Small-Cell Lung

Bayer Identifier:

10653

ClinicalTrials.gov Identifier:

NCT00044538

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of BAY 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer Patients

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.

Key Participants Requirements

Sex

Both

Age

18 Years

  • - 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

  • - 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
December 2001 - June 2004
Phase
Phase 2
Could I Receive a placebo
No
Products
Cytotoxic Taxane (BAY59-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sapir Medical Center, Meir General HospitalKfar Saba, 44281, Israel
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
Jayne Gurtler APMCMetairie, 70006, United States
Completed
Charité Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
A.O.U. Santa Maria Misericordia UDUdine, 33100, Italy
Completed
Norton Healthcare PavilionLouisville, 40202, United States
Completed
Hospital Ramón y CajalMadrid, 28034, Spain
Completed
Chaim Sheba Medical CenterTel Hashomer, 52621, Israel
Completed
A.O.U. S.G.Battista-MolinetteTorino, 10126, Italy
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Arizona Clinical Research CenterTucson, 85712, United States
Completed
A.O.U. di Modena PoliclinicoModena, 41100, Italy
Completed
Roswell Park Cancer InstituteBuffalo, 14263-0001, United States
Completed
Harold Leever Cancer CenterWaterbury, 06708-2904, United States
Completed
Juravinski Cancer CentreHamilton, L8V 5C2, Canada
Completed
Asklepios Fachkliniken München GautingGauting, 82131, Germany
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hopital LavalQuebec, G1V 4G5, Canada
Completed
Hospital General de ElcheElche, 03203, Spain
Completed
Northwestern Ontario Regional Cancer CentreThunder Bay, P7A 7T1, Canada
Completed
Tennessee Oncology, PCNashville, 37205, United States
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Hospital de CrucesBarakaldo, 48903, Spain
Completed
Hematology Oncology Consultants, Inc.Columbus, 43235, United States
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
A.O.U. di ParmaParma, 43100, Italy

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.