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Completed

NCT Number: NCT00044564

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bay 59-8862

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Duration of response

    Time frame: At baseline and every cycle during the treatment period

  2. Overall survival

    Time frame: Till end of follow up period (up to 2 years)

  3. Time to progression

    Time frame: Throughout study

  4. Pharmacokinetics assessment

    Time frame: At cycle 1

  5. Qualitative and quantitative toxicity profile

    Time frame: Day 1 of each cycle or as clinically indicated

  6. Physical examinations

    Time frame: As clinically indicated

  7. Vital signs data

    Time frame: Throughout study period

  8. Abnormal laboratory tests

    Time frame: Prior to every cycle till last study visit

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2003
First posted
Sep 4, 2002
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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