Kidney Cancer Clinical Trial
Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
Summary
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.
Full Description
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).
Eligibility 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
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There are 153 Locations for this study
Scottsdale Arizona, 85259, United States
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80224, United States
Englewood Colorado, 80110, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80502, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Boca Raton Florida, 33486, United States
Jacksonville Florida, 32224, United States
Lakeland Florida, 33805, United States
Athens Georgia, 30607, United States
Augusta Georgia, 30904, United States
Augusta Georgia, 30912, United States
Macon Georgia, 31208, United States
Aurora Illinois, 60507, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60616, United States
Chicago Illinois, 60625, United States
Decatur Illinois, 62526, United States
Elmhurst Illinois, 60126, United States
Hinsdale Illinois, 60521, United States
Joliet Illinois, 60432, United States
Joliet Illinois, 60435, United States
Libertyville Illinois, 60048, United States
Moline Illinois, 61265, United States
Niles Illinois, 60714, United States
Rockford Illinois, 61104, United States
Skokie Illinois, 60076, United States
Skokie Illinois, 60076, United States
Skokie Illinois, 60077, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46515, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Ames Iowa, 50010, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Mason City Iowa, 50401, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
West Des Moines Iowa, 50266, United States
Baton Rouge Louisiana, 70806, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Adrian Michigan, 49221, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Saginaw Michigan, 48601, United States
Saint Joseph Michigan, 49085, United States
Warren Michigan, 48093, United States
Bemidji Minnesota, 56601, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Litchfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Waconia Minnesota, 55387, United States
Lincoln Nebraska, 68502, United States
Lincoln Nebraska, 68510, United States
Lincoln Nebraska, 68510, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89106, United States
Flemington New Jersey, 08822, United States
Hamilton New Jersey, 08690, United States
New Brunswick New Jersey, 08903, United States
Bronx New York, 10461, United States
Bronx New York, 10466, United States
Stony Brook New York, 11794, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Akron Ohio, 44309, United States
Bowling Green Ohio, 43402, United States
Canton Ohio, 44708, United States
Canton Ohio, 44710, United States
Chillicothe Ohio, 45601, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Findlay Ohio, 45840, United States
Fremont Ohio, 43420, United States
Lancaster Ohio, 43130, United States
Lima Ohio, 45804, United States
Marietta Ohio, 45750, United States
Maumee Ohio, 43537, United States
Newark Ohio, 43055, United States
Oregon Ohio, 43616, United States
Sandusky Ohio, 44870, United States
Springfield Ohio, 45504, United States
Springfield Ohio, 45505, United States
Sylvania Ohio, 43560, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43623, United States
Toledo Ohio, 43623, United States
Wauseon Ohio, 43567, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Bethlehem Pennsylvania, 18015, United States
Danville Pennsylvania, 17822, United States
Harrisburg Pennsylvania, 17105, United States
Hershey Pennsylvania, 17033, United States
Lemoyne Pennsylvania, 17043, United States
Lewistown Pennsylvania, 17044, United States
Philadelphia Pennsylvania, 19107, United States
Reading Pennsylvania, 19612, United States
Sayre Pennsylvania, 18840, United States
State College Pennsylvania, 16801, United States
State College Pennsylvania, 16803, United States
West Chester Pennsylvania, 19380, United States
Wilkes-Barre Pennsylvania, 18711, United States
York Pennsylvania, 17403, United States
Aiken South Carolina, 29801, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Charleston West Virginia, 25304, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53715, United States
Marinette Wisconsin, 54143, United States
Marshfield Wisconsin, 54449, United States
Racine Wisconsin, 53405, United States
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