Status:
TERMINATED
Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
35+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib in treating ...
Detailed Description
OBJECTIVES: Primary * Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitini...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS
- No invasive disease
- Not completely excised
- Epidermal growth factor receptor (EGFR) positive (\> 10% of cells stained)
- Planned lumpectomy or mastectomy within the next 2-4 weeks
- Hormone receptor status:
- Estrogen receptor status known
- PATIENT CHARACTERISTICS:
- Age
- 35 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Granulocyte count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin \< 1.5 mg/dL
- SGOT ≤ 2 times upper limit of normal (ULN)
- SGPT \< 1.5 times ULN
- PT and PTT ≤ 1.5 times ULN
- INR ≤ 1.5 times ULN
- Renal
- Creatinine \< 1.5 mg/dL
- Cardiovascular
- No New York Heart Association class I-IV heart disease
- Pulmonary
- No acute asthma
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Random blood sugar \< 2.5 times ULN
- No known hypersensitivity to study drug or its excipients
- No nonhealing wound or fracture
- No active infection
- No other malignancy within the past 5 years except basal cell carcinoma, breast carcinoma, or carcinoma in situ of the cervix
- No psychosis or severe depression
- No other concurrent uncontrolled illness
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior trastuzumab (Herceptin®)
- Chemotherapy
- At least 1 year since prior chemotherapy
- No concurrent chemotherapy
- Endocrine therapy
- At least 1 year since prior aromatase inhibitors
- At least 1 year since prior antiestrogens or luteinizing hormone-releasing hormone agonists or antagonists
- No concurrent glucocorticoids
- Concurrent oral contraceptives allowed
- Concurrent hormone replacement therapy allowed
- Radiotherapy
- At least 1 year since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
- Recovered from prior oncologic or other major surgery
- No prior organ allograft
- Other
- Recovered from all prior therapy (except alopecia)
- More than 30 days since prior non-approved or investigational drugs
- No prior definitive local therapy
- No prior immunosuppressive therapy
- No prior gefitinib
- No other prior EGFR inhibitors
- No other concurrent cytotoxic drugs
- No concurrent warfarin for anticoagulation
- No concurrent CYP3A4 inducers, including any of the following:
- Phenytoin
- Carbamazepine
- Barbiturates
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's wort)
- Ethosuximide
- Griseofulvin
- Nafcillin
- Nelfinavir
- Nevirapine
- Oxcarbazepine
- Phenylbutazone
- Primidone
- Rifabutin
- Rofecoxib
- Sulfamethazine
- Sulfinpyrazone
- Troglitazone
- No concurrent antiretroviral treatment for HIV-positive patients
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00082667
Start Date
October 1 2002
End Date
June 1 2005
Last Update
February 25 2013
Active Locations (2)
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1
Meharry Medical College
Nashville, Tennessee, United States, 37208
2
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838