BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00039169
First received: June 6, 2002
Last updated: July 23, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: ortataxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00039169

Locations
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
United States, Indiana
Medical Consultants
Muncie, Indiana, United States, 47303
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
206 Research Associates
Greenbelt, Maryland, United States, 20770
United States, Missouri
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, Montana
Billings Oncology Associates
Billings, Montana, United States, 59101
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Theradex
Investigators
Study Chair: Marius Moscovici, MD Pharma-Clinical
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00039169     History of Changes
Other Study ID Numbers: CDR0000069359, THERADEX-100386, BAYER-100386
Study First Received: June 6, 2002
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

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

ClinicalTrials.gov processed this record on October 21, 2014