Clinical trial NCT00323063 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
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 confirmed breast cancer

               -  Locally advanced or metastatic disease

               -  Disease progression after at least 1 prior chemotherapy regimen for metastatic
                  disease

                    -  No more than 2 prior chemotherapy regimens for metastatic disease (prior
                       neoadjuvant or adjuvant treatment will not be included in determining the
                       number of prior chemotherapy regimens)

          -  Measurable disease

          -  No known symptomatic or untreated brain metastases or carcinomatous meningitis

               -  Previously treated and clinically stable brain metastases allowed provided
                  patient has been off steroids for > 7 days

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Male or female

          -  Menopausal status not specified

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 3 months

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

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

          -  AST or 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 contraception during and for 3 months after
             completion of study therapy

          -  Able to swallow oral medication

          -  No coexisting medical condition that would preclude study compliance

          -  No uncontrolled illness, including any of the following:

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia requiring therapy

               -  Myocardial infarction within the past 6 months

               -  Active infection

          -  No New York Heart Association class III-IV cardiac disease

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

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

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

          -  No known HIV infection

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy

          -  More than 2 weeks since prior surgery

          -  At least 2 weeks since prior hormonal therapy

          -  At least 2 weeks since prior trastuzumab (Herceptin®)

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

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

          -  More than 28 days since prior investigational agents

          -  At least 3 weeks since prior radiotherapy

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

          -  No prior imatinib mesylate for metastatic disease

          -  No prior gemcitabine hydrochloride for metastatic disease

          -  More than 6 months since prior adjuvant gemcitabine hydrochloride

          -  No other concurrent investigational or commercial agents

          -  No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin® or
             Coumadine®)

               -  Concurrent heparin or low-molecular weight heparin (e.g., Lovenox®) for
                  therapeutic anticoagulation allowed

               -  Concurrent prophylactic warfarin therapy (e.g., mini-dose Coumadin® ≤ 1 mg daily)
                  to maintain catheter patency allowed

          -  No concurrent routine chronic systemic corticosteroids

          -  No concurrent medications that would preclude study compliance