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Home > "T" Clinical Trials Conditions > Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer  Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer
Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer,Male Breast Cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: The monoclonal antibodytrastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as gefitinib may also interfere with the growth of tumor cells and may enhance the effects of trastuzumab. Combining trastuzumab with gefitinib may be an effective treatment for metastatic breast cancers with high amounts of HER2. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with gefitinib in treating patients who have HER2-positive breast cancer.
Details: OBJECTIVES: - Determine the response rate, duration of response, and time to progression in patients with metastatic breast cancer that overexpresses HER2-neu treated with trastuzumab (Herceptin) and gefitinib . - Determine the phase II dose of gefitinib when given in combination with trastuzumab in these patients. - Determine the toxicity of this regimen in these patients. - Determine the 3- and 6-month progression-free survival of patients treated with this regimen. - Correlate response rates with plasma levels of circulating HER2 and tumor levels of epidermal growth factor receptor, activated HER2, and HER2 receptors, as measured by immunohistochemistry and/or fluorescent in situ hybridization (FISH), in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of gefitinib. The phase I portion of this study was open in only 5 ECOG institutions. The phase I portion has been completed, and the study is being opened in all ECOG-affiliated institutions. - Patients receive trastuzumab (Herceptin) IV over 30-90 minutes once weekly and oral gefitinib once daily beginning on day 1. Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is established, additional patients are accrued to the phase II portion of the study and are treated at that dose. - Phase II: Patients receive oral gefitinib once daily (at the MTD established in phase I) and trastuzumab IV weekly until week 24, at which time trastuzumab is given every 3 weeks (with daily gefitinib) until disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for the phase I portion of this study. The phase I portion of this study has been completed. A total of 34-132 patients (15-46 previously treated with chemotherapy but not trastuzumab [Herceptin] in the metastatic setting; 19-86 not previously treated with chemotherapy or trastuzumab in the metastatic setting) will be accrued for the phase II portion of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic adenocarcinoma of the breast - Patients may have had or not had standard first-line chemotherapy for the treatment of metastatic disease - Overexpression of HER2-neu (HER2 3+ by immunohistochemistry or gene amplification as measured by fluorescent in situ hybridization) - Measurable disease - Patients with no prior adjuvant chemotherapy may have failed or not failed first-line chemotherapy for metastatic disease - No more than 2 prior systemic chemotherapy regimens for metastatic disease - Relapse while receiving or within 6 months of completion of adjuvant chemotherapy is considered failure of 1 regimen for metastatic disease - No untreated brain metastases or brain metastases undergoing radiotherapy - Previously treated brain metastasis that has responded to radiotherapy and/or surgery allowed if not sole site of measurable disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases is present) - INR no greater than 1.5 times ULN - PT and PTT no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL - No more than trace blood or protein in urine Cardiovascular: - LVEF at least 50% by MUGA scan - No prior New York Heart Association class I-IV heart disease - No PR prolongation or atrioventricular block on ECG Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception (preferably nonhormonal) - Random blood sugar less than 2.5 times ULN - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior trastuzumab (Herceptin) - No other concurrent immunologic therapy Chemotherapy: - See Disease Characteristics - No prior cumulative dose of doxorubicin more than 360 mg/m^2 - No concurrent chemotherapy Endocrine therapy: - At least 2 weeks since prior hormonal therapy - No concurrent hormonal therapy, including tamoxifen - No concurrent dexamethasone, progesterone, or glucocorticoids Radiotherapy: - See Disease Characteristics - At least 2 weeks since prior radiotherapy - No prior radiotherapy to target lesions or only site of measurable disease - No concurrent radiotherapy Surgery: - See Disease Characteristics - No prior organ allograft Other: - No prior gefitinib - No prior immunosuppressive therapy - At least 2 weeks since prior cytotoxic drugs - No concurrent carbamazepine, ethosuximide, griseofulvin, nafcillin, nelfinavir mesylate, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rofecoxib, Hypericum perforatum (St. John's Wort), sulfadimidine, sulfinpyrazone, or troglitazone - No other concurrent investigational agents - No concurrent topical eye agents - Concurrent bisphosphonates allowed for hypercalcemia and/or prophylaxis of bone metastases
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarlosArteaga, Study Chair, Vanderbilt-Ingram Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Antonio Wolff 410-614-4192
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Additional Information:
Study ID Numbers: CDR0000068896; ECOG-1100
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024154
Other Male Breast Cancer Studies:
1. Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer
2. Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
3. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
4. Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer
5. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
Related Studies:
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Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer
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