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An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses

Outcome Time Frame:

At baseline and every 2 cycles during the treatment period

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

100386

NCT ID:

NCT00044564

Start Date:

December 2001

Completion Date:

January 2003

Related Keywords:

  • Carcinoma, Renal Cell
  • Taxane
  • Renal Cell Carcinoma
  • Advanced Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
University of UtahSalt Lake City, Utah  
Washington UniversitySt. Louis, Missouri  63110
Scripps Clinic - Torrey PinesLa Jolla, California  92037
Medical Consultants, PCMuncie, Indiana  47304
Ochsner Foundation HospitalNew Orleans, Louisiana  70121-2484
University of Maryland Hospital SystemBaltimore, Maryland  21201-1595
Urology AssociatesGreenbelt, Maryland  20770
Harper University HospitalDetroit, Michigan  48201-9027
Providence HospitalSouthfield, Michigan  48075
Hematology-Oncology Centers of the Northern RockiesBillings, Montana  59101