Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00044564
First received: August 30, 2002
Last updated: June 21, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Bay 59-8862
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses [ Time Frame: At baseline and every 2 cycles during the treatment period ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: At baseline and every cycle during the treatment period ]
  • Overall survival [ Time Frame: Till end of follow up period (up to 2 years) ]
  • Time to progression [ Time Frame: Throughout study ]
  • Pharmacokinetics assessment [ Time Frame: At cycle 1 ]
  • Qualitative and quantitative toxicity profile [ Time Frame: Day 1 of each cycle or as clinically indicated ]
  • Physical examinations [ Time Frame: As clinically indicated ]
  • Vital signs data [ Time Frame: Throughout study period ]
  • Abnormal laboratory tests [ Time Frame: Prior to every cycle till last study visit ]

Enrollment: 140
Study Start Date: December 2001
Study Completion Date: January 2003
Arms Assigned Interventions
Experimental: Arm 1 Drug: Bay 59-8862
75 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044564

  Show 29 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer HealtCare Pharmaceuticals Inc., Therapeutic Area Head
ClinicalTrials.gov Identifier: NCT00044564     History of Changes
Other Study ID Numbers: 100386
Study First Received: August 30, 2002
Last Updated: June 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Taxane
Renal Cell Carcinoma
Advanced Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014