Clinical trial NCT00039429 (phase 2, status: completed)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: atrasentan hydrochloride
SMILES: CCCCN(CCCC)C(=O)CN1C[C@@H]([C@H]([C@@H]1C1=CC=C(OC)C=C1)C(O)=O)C1=CC2=C(OCO2)C=C1
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