Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: docetaxel; erlotinib hydrochloride
Intervention description: Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose.; OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.
Intervention MeSH terms: Docetaxel; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IV breast cancer; male 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.
    

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