Clinical trial NCT00044564: Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
Official title: An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Taxane
Renal Cell Carcinoma
Advanced Renal Cell Carcinoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2002-09-04
Enrollment: 54
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: In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.


Eligibility criteria: Inclusion Criteria: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - 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:
measure: Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses
timeFrame: At baseline and every 2 cycles during the treatment period
Secondary outcomes:
measure: Duration of response
timeFrame: At baseline and every cycle during the treatment period
measure: Overall survival
timeFrame: Till end of follow up period (up to 2 years)
measure: Time to progression
timeFrame: Throughout study
measure: Pharmacokinetics assessment
timeFrame: At cycle 1
measure: Qualitative and quantitative toxicity profile
timeFrame: Day 1 of each cycle or as clinically indicated
measure: Physical examinations
timeFrame: As clinically indicated
measure: Vital signs data
timeFrame: Throughout study period
measure: Abnormal laboratory tests
timeFrame: Prior to every cycle till last study visit
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Muncie
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Greenbelt
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: New Brunswick
country: United States
state: New Jersey
city: Salt Lake City
country: United States
state: Utah
city: Milwaukee
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Sudbury
country: Canada
state: Ontario
city: Caen Cedex 5
country: France
city: Montpellier Cedex
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Rotterdam
country: Netherlands
city: Plymouth
country: United Kingdom
state: Devon
city: Manchester
country: United Kingdom
state: Greater Manchester
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Sutton
country: United Kingdom
state: Surrey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: