Clinical trial NCT00044538: Evaluation of BAY 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Taxane
Lung cancer, non-small cell
NSCLC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2002-09-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Waterbury
country: United States
state: Connecticut
city: Louisville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Buffalo
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Edmonton
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Gauting
country: Germany
state: Bayern
city: Berlin
country: Germany
city: Kfar Saba
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Modena
country: Italy
city: Parma
country: Italy
city: Pisa
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
city: Elche
country: Spain
state: Alicante
city: Barakaldo
country: Spain
state: Bizkaia
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: