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Status:

COMPLETED

Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer

Lead Sponsor:

City of Hope Medical Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or del...

Detailed Description

OBJECTIVES: Primary * Determine the safety and efficacy of gefitinib, trastuzumab (Herceptin®), and docetaxel, in terms of time to disease progression, in patients with HER2/neu-overexpressing metas...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the breast
  • Metastatic disease
  • HER-2/neu overexpression (3+ by immunohistochemistry OR 2+ by fluorescence in situ hybridization)
  • Measurable or evaluable disease
  • Hormone receptor status:
  • Not specified
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Sex
  • Male or female
  • Menopausal status
  • Not specified
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • AST and ALT \< 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of liver metastases)
  • Bilirubin \< 1.5 times ULN
  • No unstable or uncompensated hepatic disease
  • Renal
  • Creatinine \< 1.6 mg/dL
  • No unstable or uncompensated renal disease
  • Cardiovascular
  • LVEF \> 45% by echocardiogram or MUGA
  • No prior New York Heart Association class I-IV heart disease
  • No prolonged PR interval or atrioventricular block on ECG
  • No unstable or uncompensated cardiac disease
  • Pulmonary
  • No unstable or uncompensated respiratory disease
  • No clinically active interstitial lung disease
  • Patients who are asymptomatic and have chronic stable radiographic changes are allowed
  • Immunologic
  • No autoimmune disorders
  • No conditions of immunosuppression
  • No severe hypersensitivity to taxane or gefitinib or any of its excipients
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior or concurrent malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
  • No other severe or uncontrolled systemic disease
  • No other acute or chronic medical condition that would preclude study participation
  • No other significant clinical disorder or laboratory finding that would preclude study participation
  • No psychiatric illness that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Prior adjuvant trastuzumab (Herceptin®) allowed if \> 6 months elapsed before disease recurrence
  • No prior trastuzumab for metastatic breast cancer
  • No prior monoclonal antibodies directed at the epidermal growth factor receptor (EGFR)
  • Chemotherapy
  • Prior adjuvant chemotherapy (or as first-line therapy for metastatic breast cancer) allowed
  • Prior adjuvant taxane allowed if completed \> 6 months before diagnosis of metastatic breast cancer
  • No prior docetaxel for metastatic breast cancer
  • Endocrine therapy
  • Prior adjuvant hormonal therapy (or as first-line therapy for metastatic breast cancer) allowed
  • No concurrent hormonal therapy
  • Concurrent steroids allowed provided dose is stable
  • Radiotherapy
  • Not specified
  • Surgery
  • Fully recovered from prior oncologic or other major surgery
  • No concurrent surgery within 7 days of gefitinib administration
  • Other
  • Recovered from prior anticancer therapy (alopecia allowed)
  • More than 30 days since prior non-approved drug or investigational agent
  • No other prior EGFR-directed therapy (i.e., tyrosine kinase inhibitors)
  • No concurrent use of any of the following medications:
  • Phenytoin
  • Carbamazepine
  • Barbiturates
  • Rifampin
  • Hypericum perforatum (St. John's wort)
  • No other concurrent anticancer therapy
  • No concurrent cardioprotective drugs
  • No concurrent oral retinoids
  • Concurrent participation in the City of Hope indium-labeled trastuzumab imaging study allowed

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2015

    Estimated Enrollment :

    31 Patients enrolled

    Trial Details

    Trial ID

    NCT00086957

    Start Date

    January 1 2004

    End Date

    August 1 2015

    Last Update

    February 27 2017

    Active Locations (6)

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

    Page 1 of 2 (6 locations)

    1

    Tower Cancer Research Foundation

    Beverly Hills, California, United States, 90211-1850

    2

    City of Hope Comprehensive Cancer Center

    Duarte, California, United States, 91010-3000

    3

    Hematology Oncology Consultants-Hemet

    Hemet, California, United States, 92543

    4

    Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center

    Long Beach, California, United States, 90806