PS-341 in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025376
• Other study ID #: 11049A
• Secondary ID: UCCRC-11049ANCI-
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2001
• Last updated: September 4, 2013
• Start date: October 2001
• Est. completion date: March 2006

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of PS-341 is more effective in treating metastatic kidney cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.

Description:

OBJECTIVES:

• 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 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2006
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3

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

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

Hepatic:

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

• AST/ALT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior immunotherapy or biotherapy allowed

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

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

Surgery:

• See Disease Characteristics

Other:

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• PS-341

Procedure:
• Tumor Biopsy

Locations

Country	Name	City	State
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	LaGrange Memorial Hospital	LaGrange	Illinois
United States	Loyola University Medical Center	Maywood	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	Oncology Care Associates, P.L.L.C.	Saint Joseph	Michigan
United States	Michiana Hematology/Oncology P.C.	South Bend	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate of PS-341 in colon cancer		9 weeks	No