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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693719
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : August 21, 2013
Last Update Posted : November 20, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Etoposide Drug: Irinotecan hydrochloride Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study: Irinotecan and Etoposide as Treatment for Refractory, Metastatic Breast Cancer
Study Start Date : August 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Etoposide and Irinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15. Etoposide 50 mg PO x14 days followed by 2 weeks off.
Drug: Etoposide
50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
Other Name: Vepesid

Drug: Irinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Other Name: Irinotecan hydrochloride trihydrate

Primary Outcome Measures :
  1. Median Time to Progression [ 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 ]
    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 Outcome Measures :
  1. Overall Survival [ 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 ]
    Still alive for a certain period of time after they were diagnosed with or started treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00693719

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United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
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Principal Investigator: Robert B. Livingston, MD University of Arizona
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Arizona Identifier: NCT00693719    
Other Study ID Numbers: 07-0327-04
P30CA016672 ( U.S. NIH Grant/Contract )
UARIZ-BIO07046 ( Other Identifier: University of Arizona )
UARIZ-143 ( Other Identifier: University of Arizona )
PFIZER-GA59608L ( Other Grant/Funding Number: Pfizer )
UARIZ-P18089 ( Other Identifier: University of Arizona )
First Posted: June 9, 2008    Key Record Dates
Results First Posted: August 21, 2013
Last Update Posted: November 20, 2015
Last Verified: August 2013
Keywords provided by University of Arizona:
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors