BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Cancer
• Intervention / Treatment: Drug: ortataxel

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT

Collaborators and Investigators

• Sponsor: Theradex
• Investigators: Study Chair: Marius Moscovici, MD, Pharma-Clinical

Study record dates

Study Major Dates

• Study Start: December 1, 2001

Study Registration Dates

• First Submitted: June 6, 2002
• First Submitted That Met QC Criteria: July 7, 2003
• First Posted (ESTIMATE): July 8, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): July 24, 2008
• Last Update Submitted That Met QC Criteria: July 23, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; recurrent renal cell cancer; stage III renal cell cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Antineoplastic Agents; IDN 5109
• Other Study ID Numbers: CDR0000069359; THERADEX-100386; BAYER-100386