Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2002 |
| End Date: | November 2012 |
A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer
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.
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.
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.
- 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.
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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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
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