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A Phase II Trial of PS-341 in Patients With Renal Cell Cancer

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

A Phase II Trial of PS-341 in Patients With Renal Cell Cancer


- Determine the objective response rate in patients with metastatic renal cell cancer
treated with bortezomib.

- Determine the time to tumor progression and 1-year survival of patients treated with
this drug.

- Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2.
Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Patients then undergo core biopsy.

- Arm II: Patients undergo core biopsy. Patients then receive bortezomib IV as in arm I.

Patients undergo radiologic re-evaluation of measurable lesions. Patients with stable
disease or a partial or complete response continue to receive bortezomib in the absence of
disease progression or unacceptable toxicity.

Patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 9-14

Inclusion Criteria


- Histologically or cytologically confirmed metastatic renal cell cancer

- Measurable disease

- At least 2.0 cm in at least 1 dimension by physical exam OR at least 1.0 cm in
at least 1 dimension by radiologic exam

- Single measurable lesion must not be within prior radiotherapy portal

- Tumor lesion amenable to core biopsy

- At least 1 cm of tumor obtainable

- No active CNS metastatic disease

- Single previously resected CNS metastasis allowed provided no disease
progression 8 weeks after therapy and no longer requiring steroids or
antiseizure medications



- 18 and over

Performance status:

- Not specified

Life expectancy:

- More than 3 months


- WBC at least 3,000/mm^3

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

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


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

- AST/ALT no greater than 2.5 times ULN


- Creatinine no greater than 2.0 mg/dL


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- No other uncontrolled concurrent illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier-method contraception during and for 3
months after study participation


Biologic therapy:

- Prior immunotherapy or biotherapy allowed


- No prior chemotherapy

Endocrine therapy:

- See Disease Characteristics


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to 25% or more of bone marrow (i.e., whole pelvis)


- See Disease Characteristics


- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate of PS-341 in colon cancer

Outcome Time Frame:

9 weeks

Safety Issue:


Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

March 2006

Related Keywords:

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



University of Chicago Cancer Research Center Chicago, Illinois  60637
Loyola University Medical Center Maywood, Illinois  60153
Ingalls Memorial Hospital Harvey, Illinois  60426
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
Cancer Care Specialists of Central Illinois, S.C. Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617
Oncology Care Associates, P.L.L.C. Saint Joseph, Michigan  49085
LaGrange Memorial Hospital LaGrange, Illinois  60525