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Home > "G" Clinical Trials Conditions > Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer  Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Norris Cotton Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 uptake of estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant (stopped responding) to tamoxifen. PURPOSE: Randomizedphase II trial to compare the effectiveness of gefitinib with or without tamoxifen in treating patients who have metastatic breast cancer that has stopped responding to tamoxifen.
Details: 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 effects of these regimens in these patients. - Determine whether changes in fludeoxyglucose F 18 uptake by positron emission tomography scan and changes in plasma DNA levels are indicators of an early response to gefitinib in these patients. - Determine the pharmacokinetics of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to population (intent-to-treat population comprising all patients who receive 1 dose of treatment vs a subset of the intent-to-treat population, excluding patients with nonmeasurable/evaluable only disease). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral tamoxifen once daily. Beginning 14 days after the start of tamoxifen, patients receive oral gefitinib once daily. - Arm II: Patients receive oral placebo once daily. Beginning 14 days after the start of placebo, patients receive oral gefitinib as in arm I. In both arms, treatment continues for 26 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for 6 months. PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study within 23 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchwartz, Principal Investigator, Norris Cotton Cancer Center
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Gary Schwartz 603-650-6700
Additional Information:
Study ID Numbers: CDR0000355145; DMS-0236,ZENECA-IRUSIRES0162
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080743
Other Stage 4 Breast Cancer Studies:
1. Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
2. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
3. Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer
4. Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
5. Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other New Hampshire Clinical Trials
Other Lebanon Clinical Trials
Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
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