Status:
COMPLETED
Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Norris Cotton Cancer Center
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by t...
Detailed Description
OBJECTIVES: Primary * Compare the rate of clinical benefit in patients with tamoxifen-resistant breast cancer treated with gefitinib with or without tamoxifen. Secondary * Determine the toxic effe...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Metastatic disease
- Initial clinical benefit from tamoxifen for metastatic disease, defined by 1 of the following:
- Stable disease for 24 weeks or longer
- Objective tumor response
- Documentation of clinical progression on tamoxifen within the past 6 weeks
- Hormone receptor status:
- Estrogen or progesterone receptor positive on most recently analyzed biopsy
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Not specified
- Menopausal status
- Not specified
- Performance status
- ECOG 0-2
- Life expectancy
- At least 6 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- AST ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 50 mL/min
- Pulmonary
- No clinically active interstitial lung disease
- Patients with asymptomatic chronic stable radiographic changes are eligible
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No known hypersensitivity to gefitinib
- No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent trastuzumab (Herceptin®)
- Chemotherapy
- No concurrent cytotoxic chemotherapy
- Endocrine therapy
- See Disease Characteristics
- At least 2 weeks since other prior tamoxifen
- No concurrent hormone replacement therapy
- No other concurrent antiestrogens, including raloxifene
- No concurrent aromatase inhibitors
- No concurrent megestrol
- Concurrent systemic steroids for reasons other than skin toxicity allowed provided the steroids were initiated before study entry AND dose remains stable
- Radiotherapy
- Concurrent palliative radiotherapy as short-term treatment for symptomatic bone metastases allowed provided other evaluable sites of disease are present AND treatment lasts no more than 14 days
- Surgery
- Recovered from prior oncologic or other major surgery
- No concurrent surgery during and for 7 days after study treatment
- No concurrent ophthalmic surgery
- Other
- Recovered from all prior therapy (except alopecia)
- More than 30 days since prior investigational drugs
- No other concurrent investigational agents
- No concurrent administration of any of the following:
- Phenytoin
- Carbamazepine
- Barbiturates
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's wort)
- Systemic retinoids
- CYP3A4 inhibitors (e.g., itraconazole)
- Drugs that cause significant sustained elevation in gastric pH ≥ 5
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00080743
Start Date
January 1 2004
End Date
November 1 2005
Last Update
August 6 2009
Active Locations (1)
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1
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756