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Status:

COMPLETED

Lapatinib and Epirubicin in Treating Patients With Metastatic Breast Cancer. ICORG 06-30

Lead Sponsor:

Cancer Trials Ireland

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-120 years

Phase:

PHASE1

Brief Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growt...

Detailed Description

OBJECTIVES: Primary * To assess the safety and tolerability of fixed-dose lapatinib ditosylate in combination with epirubicin hydrochloride in patients with metastatic breast cancer. * To determine ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Confirmed diagnosis of breast cancer
  • Metastatic disease
  • No de novo metastasis
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Life expectancy \> 3 months
  • Menopausal status not specified
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9 g/dL
  • Creatinine clearance ≥ 50 mL/min
  • AST/ALT \< 3 times upper limit of the normal (ULN)
  • Total bilirubin normal (unless documented history of congenital hypobilirubinemia)
  • LVEF normal by ECHO or MUGA scan
  • Not pregnant or breastfeeding
  • Negative pregnancy test
  • Fertile patients must use effective contraception from the time of their negative pregnancy test before treatment, during treatment, and 28 days following treatment
  • Able to swallow and retain oral medication
  • History of other malignancies (e.g., cervical carcinoma in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin) allowed provided patient has been treated and disease free ≥ 5 years and deemed by the investigator to be at low risk for recurrence
  • No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib ditosylate or excipients
  • No malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis
  • No active or uncontrolled infection
  • No known history of uncontrolled or symptomatic angina, arrhythmias, congestive heart failure, or other cardiac disorders
  • No history of prolonged QT interval
  • No active hepatic or biliary disease (except for Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • No concurrent disease or condition that would render the patient inappropriate for study participation, or serious medical disorder that would interfere with the patient's safety
  • No dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
  • PRIOR CONCURRENT THERAPY:
  • Prior radiotherapy for treatment of primary tumor allowed
  • Prior non-anthracycline based regimens in neoadjuvant, adjuvant, or metastatic setting allowed
  • Prior adjuvant Herceptin® or ErbB inhibitors allowed provided disease progression was \> 6 months after completion of treatment
  • More than 3 months since prior Herceptin®, ErbB1, or ErbB2
  • No prior chemotherapy in the adjuvant or neoadjuvant setting with anthracycline or anthracenedione-containing regimens
  • More than 3 weeks since prior and no concurrent medications that would prolong QT interval
  • More than 1 month or 5 half-lives (whichever is longer) since prior, no concurrent investigational drugs
  • No unresolved or unstable, serious toxicity from prior investigational drug and/or cancer treatment
  • At least 3 weeks since prior and no concurrent prohibited medications (i.e., CYP3A4 inducers or inhibitors)
  • No concurrent non-study anticancer therapy (i.e., chemotherapy, immunotherapy, or biologic therapy)
  • No concurrent participation in another clinical trial
  • No concurrent grapefruit or grapefruit juice
  • Concurrent bisphosphonates allowed

Exclusion

    Key Trial Info

    Start Date :

    October 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2012

    Estimated Enrollment :

    10 Patients enrolled

    Trial Details

    Trial ID

    NCT00753207

    Start Date

    October 1 2007

    End Date

    March 1 2012

    Last Update

    February 15 2016

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    The Adelaide and Meath Hospital, Dublin Incorporating the National Childresn's Hospital

    Dublin, Ireland, 24

    2

    St Vincent's University Hospital

    Dublin, Ireland, 4

    3

    St James's Hospital

    Dublin, Ireland, 8