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BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ortataxel
Sponsored by
Theradex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced renal cell cancer Unresectable, refractory, and/or metastatic At least 1 measurable lesion A CNS lesion cannot be the sole target lesion Lesions within a previously irradiated field are not considered measurable No metastatic brain or meningeal tumors unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic: Total bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement) PT, INR, and PTT less than 1.5 times ULN No chronic hepatitis B or C Renal: Creatinine no greater than 2 times ULN Cardiovascular: No clinically evident congestive heart failure No serious cardiac arrhythmias No prior coronary artery disease or ischemia Other: No prior hypersensitivity to taxane compounds that was not considered clinically manageable with premedication No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) No substance abuse or medical, psychological, or social conditions that would preclude study compliance No active clinically serious infections No other condition that is unstable or would preclude study participation No grade 2 or greater pre-existing peripheral neuropathy No history of seizure disorder Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 months since prior bone marrow or peripheral blood stem cell transplantation No more than 2 prior immunotherapy regimens (interleukin-2 or interferon only) At least 4 weeks since prior immunotherapy At least 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF]) More than 4 weeks since prior thalidomide or bevacizumab No prior anticancer vaccines No concurrent prophylactic G-CSF Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months before study Chemotherapy: No prior systemic cytotoxic chemotherapy No prior oxaliplatin No other concurrent anticancer chemotherapy Endocrine therapy: Patients with prior metastatic brain or meningeal tumors: No concurrent acute or tapered steroid therapy Concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies No hormonal therapy for renal cell cancer Radiotherapy: See Disease Characteristics More than 4 weeks since prior radiotherapy No prior radiotherapy to target lesion identified for this study unless progression within the radiation portal is documented Concurrent palliative radiotherapy allowed provided: No progressive disease No more than 10% of bone marrow is irradiated Radiation field does not encompass a target lesion No other concurrent radiotherapy Surgery: At least 4 weeks since prior surgery No prior organ allograft Other: At least 4 weeks since prior investigational drugs No other concurrent investigational therapy or approved anticancer therapy No concurrent illicit drugs or other substances that would preclude study Concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with PT, INR, or PTT Concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints Concurrent bisphosphonates for prophylaxis or bone metastases allowed

Sites / Locations

  • Scripps Clinic
  • Medical Consultants
  • Ochsner Clinic
  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
  • 206 Research Associates
  • St. Louis University Health Sciences Center
  • Billings Oncology Associates
  • Cancer Institute of New Jersey
  • State University of New York - Upstate Medical University
  • Huntsman Cancer Institute
  • Medical College of Wisconsin
  • Tom Baker Cancer Center - Calgary
  • Cross Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
July 23, 2008
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00039169
Brief Title
BAY 59-8862 in Treating Patients With Advanced Kidney Cancer
Official Title
An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have advanced kidney cancer.
Detailed Description
OBJECTIVES: Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with advanced renal cell cancer treated with BAY 59-8862. Determine the overall survival in patients treated with this drug. Determine the time to progression in patients treated with this drug. Determine the duration of response (CR and PR) in patients treated with this drug. Determine the qualitative and quantitative toxicity profile of this drug in this patient population. Determine the pharmacokinetic profile of this drug in selected patients. OUTLINE: This is a multicenter study. Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years. PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ortataxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced renal cell cancer Unresectable, refractory, and/or metastatic At least 1 measurable lesion A CNS lesion cannot be the sole target lesion Lesions within a previously irradiated field are not considered measurable No metastatic brain or meningeal tumors unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic: Total bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement) PT, INR, and PTT less than 1.5 times ULN No chronic hepatitis B or C Renal: Creatinine no greater than 2 times ULN Cardiovascular: No clinically evident congestive heart failure No serious cardiac arrhythmias No prior coronary artery disease or ischemia Other: No prior hypersensitivity to taxane compounds that was not considered clinically manageable with premedication No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) No substance abuse or medical, psychological, or social conditions that would preclude study compliance No active clinically serious infections No other condition that is unstable or would preclude study participation No grade 2 or greater pre-existing peripheral neuropathy No history of seizure disorder Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 months since prior bone marrow or peripheral blood stem cell transplantation No more than 2 prior immunotherapy regimens (interleukin-2 or interferon only) At least 4 weeks since prior immunotherapy At least 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF]) More than 4 weeks since prior thalidomide or bevacizumab No prior anticancer vaccines No concurrent prophylactic G-CSF Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months before study Chemotherapy: No prior systemic cytotoxic chemotherapy No prior oxaliplatin No other concurrent anticancer chemotherapy Endocrine therapy: Patients with prior metastatic brain or meningeal tumors: No concurrent acute or tapered steroid therapy Concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies No hormonal therapy for renal cell cancer Radiotherapy: See Disease Characteristics More than 4 weeks since prior radiotherapy No prior radiotherapy to target lesion identified for this study unless progression within the radiation portal is documented Concurrent palliative radiotherapy allowed provided: No progressive disease No more than 10% of bone marrow is irradiated Radiation field does not encompass a target lesion No other concurrent radiotherapy Surgery: At least 4 weeks since prior surgery No prior organ allograft Other: At least 4 weeks since prior investigational drugs No other concurrent investigational therapy or approved anticancer therapy No concurrent illicit drugs or other substances that would preclude study Concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with PT, INR, or PTT Concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints Concurrent bisphosphonates for prophylaxis or bone metastases allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Moscovici, MD
Organizational Affiliation
Pharma-Clinical
Official's Role
Study Chair
Facility Information:
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Medical Consultants
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
206 Research Associates
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Billings Oncology Associates
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

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BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

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