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Atrasentan in Treating Patien...

Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-14

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.

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Detailed Description

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OBJECTIVES:

* Determine the 6-month progression-free survival rate, in terms of proportion of those with measurable disease or bone metastases only, of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum closed to accrual as of 7/16/04).
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone metastases only) (measurable disease stratum closed to accrual as of 7/16/04).

Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per stratum \[with or without prior therapy\]) will be accrued for this study within 6 months (based on prior accrual, the bone metastases only group \[specifically patients who have received 1 prior therapy\] is the only stratum open for accrual).

Conditions

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Kidney Cancer

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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atrasentan hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection
* Progressive disease, defined by 1 of the following:

* The appearance of 1 or more new lesions
* At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) (measurable disease stratum closed to accrual as of 7/16/04.)
* One of the following disease characteristics:

* Disease manifested solely by bone metastases
* At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)

* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 2,000/mm\^3 OR
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL

Hepatic:

* Bilirubin less than 1.5 mg/dL
* AST and/or ALT less than 1.5 times upper limit of normal (ULN)

Renal:

* Creatinine less than 1.5 times ULN

Cardiovascular:

* No history of New York Heart Association class II-IV heart disease

Pulmonary:

* No significant pulmonary disease requiring pulse steroid therapy within the past 3 months

Other:

* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No other serious concurrent medical illness that would preclude study participation
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior biologic therapy/immunotherapy and recovered
* No more than 1 prior regimen\* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)

* Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: \*A regimen is considered to be at least 4 weeks of treatment

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered
* Prior radiotherapy for local control or palliation of painful bony lesion allowed
* No prior radiotherapy to target lesions
* No concurrent radiotherapy for palliation or any other indication

Surgery:

* At least 4 weeks since prior surgery and recovered
* Prior nephrectomy allowed

Other:

* Prior bisphosphonates allowed

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Eastern Cooperative Oncology Group

Principal Investigators

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Michael A. Carducci, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center

Boca Raton, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

Northeast Georgia Cancer Care, LLC

Athens, Georgia, United States

Site Status

Veterans Affairs Medical Center - Augusta

Augusta, Georgia, United States

Site Status

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Site Status

Medical Center of Central Georgia

Macon, Georgia, United States

Site Status