Clinical trial NCT00323791 (phase 2, status: terminated)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: gemcitabine hydrochloride, imatinib mesylate
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed renal cell carcinoma

               -  Metastatic disease OR unresectable primary tumor

               -  No known curative therapy exists

          -  Documented progressive renal cell carcinoma as defined by RECIST criteria within the
             past 6 months

          -  Measurable disease with ≥ 1 unidimensionally measurable lesion

          -  No known symptomatic brain metastasis or untreated brain metastases or carcinomatous
             meningitis

               -  Treated brain metastasis allowed provided the following criteria are met:

                    -  Clinically stable

                    -  More than 7 days since prior steroids

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 3 months

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective nonhormonal contraception during and for 3 months
             after completion of study treatment

          -  Must be able to swallow oral medication

          -  No coexisting medical condition that would preclude study compliance

          -  No history of allergic reaction to compounds of similar chemical or biological
             composition to gemcitabine hydrochloride and/or imatinib mesylate

          -  No uncontrolled illness that would preclude study participation

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia requiring therapy

          -  No myocardial infarction within the past 6 months

          -  No active infection

          -  No other malignancy within the past 5 years except carcinoma in situ of the cervix or
             nonmelanoma skin cancer

          -  No New York Heart Association class III-IV congestive heart failure

          -  No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

          -  No known HIV positivity

          -  No significant history of noncompliance to medical regimens

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy

          -  No more than 3 prior treatment regimens, including any of the following:

               -  No more than 1 prior cytotoxic therapy

               -  Immunotherapy regimens comprising interferon and/or aldesleukin

               -  Therapy with molecular targets

               -  Any combination of the above treatments to a maximum of 3 total therapies

          -  No prior gemcitabine hydrochloride for metastatic disease

          -  No prior imatinib mesylate for metastatic disease

          -  More than 2 weeks since prior major surgery

          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

          -  At least 3 weeks since prior anti-vascular endothelial growth factor therapy

          -  At least 3 weeks since prior radiotherapy

               -  Must have evidence of ≥ 1 measurable target lesion outside the radiation fields
                  OR radiologically confirmed disease progression within the radiation fields after
                  completion of radiotherapy

          -  At least 28 days since prior and no other concurrent investigational or commercial
             agents, unless disease is rapidly progressing

          -  No concurrent therapeutic warfarin

               -  Concurrent low molecular weight heparin or heparin allowed for therapeutic
                  anticoagulation

               -  Concurrent prophylactic warfarin therapy ≤ 1 mg daily to maintain catheter
                  patency allowed

          -  No concurrent filgrastim (G-CSF) for prevention of neutropenia

          -  No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiation
             therapy, or cancer surgery

          -  No concurrent routine use (i.e., daily or every other day) of systemic corticosteroid
             therapy (in supraphysiologic doses)

          -  No concurrent medication that would preclude study compliance