Clinical trial NCT00693719: Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
Official title: A Phase II Study: Irinotecan and Etoposide as Treatment for Refractory, Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-06-09
Enrollment: 31
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Median Time to Progression
timeFrame: 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
Secondary outcomes:
measure: Overall Survival
timeFrame: 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
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center at University of Arizona Health Sciences Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Robert B. Livingston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segar JM, Reed D, Stopeck A, Livingston RB, Chalasani P. A Phase II Study of Irinotecan and Etoposide as Treatment for Refractory Metastatic Breast Cancer. Oncologist. 2019 Dec;24(12):1512-e1267. doi: 10.1634/theoncologist.2019-0516. Epub 2019 Aug 5.