Breast Cancer Clinical Trial
Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer.
Full Description
OBJECTIVES:
Determine the antitumor effects of erlotinib and docetaxel, in terms of objective response, stabilization of disease, and progression-free survival, in patients with stage IV or recurrent breast cancer.
Determine time to tumor progression in patients treated with this regimen.
Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib.
OUTLINE: Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1. Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-14 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV or recurrent adenocarcinoma of the breast
Measurable disease
Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel
Stable brain metastases allowed
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Male or female
Menopausal status
Not specified
Performance status
ECOG (Eastern Cooperative Oncology Group) 0-2 OR
Karnofsky 60-100%
Life expectancy
More than 6 months
Hematopoietic
WBC(White Blood Count) at least 3,000/mm^3
Platelet count at least 100,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Hemoglobin at least 8 g/dL
Hepatic
Bilirubin normal
AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal
Renal
Creatinine normal OR
Creatinine clearance at least 60 mL/min
No clinically significant proteinuria
No significant impairment of renal function
Cardiovascular
No New York Heart Association class III or IV heart disease
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No inadequately controlled hypertension
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80
No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer
No ongoing or active infection
No peripheral neuropathy greater than grade 1
No other concurrent uncontrolled medical condition that would preclude study participation
No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior trastuzumab (Herceptin) allowed
Chemotherapy
See Disease Characteristics
No prior chemotherapy for recurrent or metastatic disease
Prior adjuvant chemotherapy allowed
Endocrine therapy
Prior hormonal therapy allowed
Radiotherapy
Not specified
Surgery
Not specified
Other
No other concurrent investigational agents
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There is 1 Location for this study
Cleveland Ohio, 44106, United States
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