Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: gemcitabine hydrochloride; imatinib mesylate
Intervention description: Given IV; Given orally
Intervention MeSH terms: Gemcitabine; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IV breast cancer; male breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor
      cells.

      PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see
      how well they work compared to gemcitabine alone in treating patients with previously treated
      locally advanced or metastatic breast cancer.
    

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