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Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer

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Trial Information

Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma


- Determine the tumor response rate of patients with recurrent, unresectable, or
metastatic renal cell carcinoma treated with BAY 56-3722.

- Determine the duration of response, time to progression, and survival of patients
treated with this drug.

- Determine the qualitative and quantitative toxic effects of this drug in these

- Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks
for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed renal cell carcinoma (RCC)

- Recurrent AND unresectable disease OR

- Unresectable disease OR

- Metastatic disease

- At least 1 bidimensionally measurable lesion by CT scan or MRI

- No metastatic brain or meningeal tumors unless more than 3 months since prior surgery
and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4
weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants



- 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 g/dL


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)

- No chronic hepatitis B or C


- Creatinine no greater than 1.5 mg/dL

- Calcium normal


- No clinically evident congestive heart failure

- No serious cardiac arrhythmias

- No symptoms of coronary heart disease

- No symptoms of ischemia


- HIV negative

- No active infections requiring systemic antibacterial, antifungal, or antiviral

- 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

- No medical, psychological, or social conditions that would preclude study

- No known or suspected allergy to study drug or any other study agents

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months
after study


Biologic therapy:

- No prior anticancer vaccine therapy

- No prior bone marrow transplantation or stem cell rescue

- More than 4 weeks since prior thalidomide and bevacizumab

- At least 4 weeks since prior interleukin-2 and interferon

- No more than 2 prior regimens

- No concurrent bone marrow transplantation or stem cell rescue


- No prior cytotoxic chemotherapy

- No concurrent cytotoxic chemotherapy

Endocrine therapy:

- See Disease Characteristics

- No prior hormonal therapy for RCC

- No concurrent hormonal therapy for RCC


- See Disease Characteristics

- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to indicator lesion unless progression is documented


- See Disease Characteristics

- More than 3 weeks since prior major surgery


- At least 4 weeks since prior investigational anticancer drugs

- No other concurrent investigational anticancer drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Barbara J. Gitlitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Stage IV Renal Cell Cancer
  • Recurrent Renal Cell Cancer
  • Carcinoma, Renal Cell



Baylor College of MedicineHouston, Texas  77030
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Colorado Cancer CenterDenver, Colorado  80262
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
Loyola University Medical CenterMaywood, Illinois  60153
Tulane University School of MedicineNew Orleans, Louisiana  70112
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
University of Rochester Medical CenterRochester, New York  14642
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Oregon Cancer InstitutePortland, Oregon  97201-3098
Oncology-Hematology Group of South FloridaMiami, Florida  33176
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Cancer Therapy and Research CenterSan Antonio, Texas  78229