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

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

Thank you

Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL


- 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


- Creatinine no greater than 2 times ULN


- No clinically evident congestive heart failure

- No serious cardiac arrhythmias

- No prior coronary artery disease or ischemia


- 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

- 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


Biologic therapy:

- At least 4 months since prior bone marrow or peripheral blood stem cell

- 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


- 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


- 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


- At least 4 weeks since prior surgery

- No prior organ allograft


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Marius Moscovici, MD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

December 2001

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
State University of New York - Upstate Medical University Syracuse, New York  13210
Huntsman Cancer Institute Salt Lake City, Utah  84112
Medical College of Wisconsin Milwaukee, Wisconsin  53226
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
Scripps Clinic La Jolla, California  92037
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Ochsner Clinic New Orleans, Louisiana  70121
206 Research Associates Greenbelt, Maryland  20770
Billings Oncology Associates Billings, Montana  59101
Medical Consultants Muncie, Indiana  47304