Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Etoposide; Irinotecan hydrochloride
Intervention description: 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle; Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Intervention MeSH terms: Irinotecan; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide
      works in treating patients with recurrent, locally advanced, or metastatic breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of locally advanced or metastatic breast cancer

               -  Recurrent, refractory or progressive disease after receiving prior anthracycline,
                  taxane, and capecitabine therapy

                    -  Prior anthracycline and taxane therapy may have been as neoadjuvant, or
                       adjuvant therapy if disease progression is documented within a year of
                       completing that agent

                    -  Received prior capecitabine therapy for metastatic or recurrent disease

          -  Measurable disease

               -  Bone metastases requires other disease present that can be measured

          -  No brain metastases, unless documented to be controlled post-completion of local
             therapy (surgery and/or radiation therapy) for at least 4 weeks

          -  No meningeal carcinomatosis

          -  No malignant effusion as the only site of disease recurrence

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Menopausal status not specified

          -  Performance status of 0-2

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 40 mL/min

          -  Hemoglobin ≥ 10 g/dL

          -  ANC ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin normal or hyperbilirubinemia < grade 1 (unless due to Gilbert syndrome with
             elevated total but normal levels of conjugated bilirubin)

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other non-breast malignancy, except nonmelanoma skin cancer

          -  No other serious underlying medical condition, that in the opinion of the treating
             physician, would make study protocol unreasonably hazardous for the patient or would
             preclude the patient's ability to comply with the study protocol

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristic

          -  Recovered from all prior chemotherapy or radiotherapy to NCI CTC grade ≤ 1

          -  Unlimited documented prior chemotherapy regimens allowed

          -  No prior irinotecan hydrochloride or etoposide

          -  No Hypericum perforatum (St. John's wort) 14 days prior to, during, or 7 days after
             completion of study therapy

          -  At least 7 days since prior and no concurrent phenytoin, carbamazepine, phenobarbital,
             or any other enzyme-inducing anticonvulsant drug (EIACD)

          -  No concurrent aprepitant