Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Study: Irinotecan and Etoposide as Treatment for Refractory, Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693719
• Other study ID #: 07-0327-04
• Secondary ID: P30CA016672UARIZ
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2008
• Last updated: October 15, 2015
• Start date: August 2007
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Etoposide
50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
• Irinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle

Locations

Country	Name	City	State
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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	No
Secondary	Overall Survival	Still alive for a certain period of time after they were diagnosed with or started treatment	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	No