GTI-2040 and Capecitabine in Treating Patients With Metastatic Breast Cancer
Condition: Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms; Breast Neoplasms, Male
Intervention: GTI-2040; capecitabine
Intervention description: Given IV; Given orally
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving GTI-2040 together with capecitabine works in
      treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as
      capecitabine, work in different ways to stop tumor cells from dividing so they stop growing
      or die. GTI-2040 may help capecitabine kill more tumor cells by making them more sensitive to
      the drug
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed metastatic adenocarcinoma
             of the breast

          -  Patients must have measurable disease, defined as lesions that can be accurately
             measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with
             conventional techniques or as >= 10 mm with spiral CT scan

          -  Patients must have progressed on at least one but no more than two prior chemotherapy
             regimens for metastatic disease; patients must not have received prior capecitabine or
             5-fluorouracil; patients with hormone-sensitive tumors should have received hormone
             treatment and any prior number of hormonal agents will be allowed; patients with
             tumors that overexpress HER-2/neu (3+ by immunohistochemistry or amplified by
             fluorescent in situ hybridization) should have received herceptin, either in the
             adjuvant or metastatic setting, unless there is a contraindication to herceptin
             therapy; all prior therapies must have been completed 4 weeks before treatment

          -  Life expectancy of greater than 3 months

          -  ECOG performance status =< 2 (Karnofsky >= 50%)

          -  Leukocytes >= 3,000/μL

          -  Absolute neutrophil count >= 1,500/μL

          -  Platelets >= 100,000/μL

          -  Total bilirubin within normal institutional limits

          -  AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min

          -  Patients must have completed radiation treatment > 4 weeks prior to study entry;
             previously radiated area(s) must not be the only site of disease

          -  All major surgical procedures must be completed > 4 weeks prior to study entry;
             placement of vascular access device or tissue biopsy will not be considered major
             surgery

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Patients must agree to the placement of a central venous catheter in order to receive
             the continuous infusion treatment

        Exclusion Criteria:

          -  Patients with only non-measurable disease, defined as all other lesions, including
             small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with
             spiral CT scan) and truly non-measurable lesions, which include the following:

               -  bone lesions

               -  leptomeningeal disease

               -  ascites

               -  pleural/pericardial effusion

               -  inflammatory breast disease

               -  lymphangitis cutis/pulmonis

               -  abdominal masses that are not confirmed and followed by imaging techniques

               -  cystic lesions

          -  Patients who have had chemotherapy, hormone therapy, or radiotherapy within 4 weeks (6
             weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have
             not recovered from adverse events due to agents administered more than 4 weeks earlier

          -  Patients may not be receiving any other investigational agents; patients may not have
             received prior GTI-2040

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to GTI-2040 or to capecitabine or 5-fluorouracil

          -  Patients requiring anticoagulant therapy; low-dose anticoagulant (warfarin 1 mg per
             day) for the primary prophylaxis of venous catheter-associated thrombosis is permitted

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study because GTI-2040 and capecitabine have the
             potential for teratogenic or abortifacient effects; because there is an unknown but
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with GTI-2040 and capecitabine, breastfeeding should be discontinued if the
             mother is treated

          -  Because patients with immune deficiency are at increased risk of lethal infections
             when treated with marrow-suppressive therapy, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions with GTI-2040 or other agents administered during the
             study; appropriate studies will be undertaken in patients receiving combination
             anti-retroviral therapy when indicated