Breast Cancer
Conditions
Keywords
recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * To determine the response rate, as assessed by RECIST criteria, in patients with recurrent locally advanced or metastatic breast cancer treated with irinotecan hydrochloride and etoposide after prior exposure to anthracycline, taxane, and capecitabine therapy. Secondary * To determine the median time to progression in these patients. * To determine the response duration and survival in these patients. * To measure the type and rate of grade 3 or greater toxicity of this treatment regimen in these patients. OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity. After completion of study therapy, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
Interventions
DRUGEtoposide
50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
DRUGIrinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Sponsors
National Cancer Institute (NCI)
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Progression | Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months | Still alive for a certain period of time after they were diagnosed with or started treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etoposide/Irinotecan Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Etoposide/Irinotecan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 54.68 years STANDARD_DEVIATION 11.33 |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 31 |
| serious Total, serious adverse events | 4 / 31 |
Outcome results
Primary
Median Time to Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Etoposide/Irinotecan | Median Time to Progression | 149 Days | Standard Error 33.83 |
Secondary
Overall Survival
Still alive for a certain period of time after they were diagnosed with or started treatment
Time frame: Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etoposide/Irinotecan | Overall Survival | 149 Days |