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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00693719
First received: June 6, 2008
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Etoposide
Drug: Irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE II STUDY: IRINOTECAN AND ETOPOSIDE AS TREATMENT FOR REFRACTORY, METASTATIC BREAST CANCER

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Still alive for a certain period of time after they were diagnosed with or started treatment


Enrollment: 31
Study Start Date: August 2007
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etoposide/Irinotecan Drug: Etoposide
50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
Drug: Irinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693719

Locations
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
Investigators
Principal Investigator: Robert B. Livingston, MD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00693719     History of Changes
Other Study ID Numbers: 07-0327-04, P30CA016672, UARIZ-BIO07046, UARIZ-143, PFIZER-GA59608L, UARIZ-P18089
Study First Received: June 6, 2008
Results First Received: June 12, 2013
Last Updated: August 21, 2013
Health Authority: United States: Food and Drug Administration

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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Etoposide
Irinotecan
Camptothecin
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014