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
18 Years
N/A
Both
Breast Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000
Outcome Description:
Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.
Outcome Time Frame:
after 6 course (6 months) of combination therapy
Safety Issue:
No
Principal Investigator
Paula Silverman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CWRU1102
NCT ID:
NCT00054275
Start Date:
December 2002
Completion Date:
November 2012
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- stage IV breast cancer
- male breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
