Colon Cancer Clinical Trial

PS-341 in Treating Patients With Metastatic Kidney Cancer

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

23

Study ID:

NCT00025376

Recruitment Status:

Completed

Sponsor:

University of Chicago

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There are 10 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

23

Study ID:

NCT00025376

Recruitment Status:

Completed

Sponsor:


University of Chicago

How clear is this clinincal trial information?

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