|
Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane Clinical research trials and Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane. Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane clinical trial. Subjects frequently get the best healthcare possible for their Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane  Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane
Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane
For Condition: recurrent breast cancer,stage 4 breast cancer,Male Breast Cancer
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with erlotinib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with erlotinib in treating patients who have metastatic breast cancer that has been previously treated with an anthracycline and/or a taxane.
Details: OBJECTIVES: - Determine the anti-tumor activity of erlotinib and gemcitabine in patients with metastatic breast cancer previously treated with anthracycline and/or taxane. - Determine the adverse event profile of this regimen in these patients. - Determine whether epidermal growth factor receptor and HER-2 receptor intensity and serum concentrations have an impact on clinical response in patients treated with this regimen. - Determine the impact of genetic differences in proteins involved in drug response (transport, metabolism, and mechanism of action) on clinical response and adverse events associated with gemcitabine in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on days 1 and 8 and oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for up to 5 years or until disease progression (PD); patients with PD are then followed every 3 months for up to 5 years. PROJECTED ACCRUAL: A total of 5-56 patients will be accrued for this study within 20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Clinical evidence of metastatic disease - Candidate for first- or second-line chemotherapy for metastatic disease - Must have received prior anthracycline or taxane therapy (may have had both in the neoadjuvant, adjuvant, or metastatic setting) - At least 1 measurable lesion at least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan - The following are not considered measurable disease: - Small lesions less than 20 mm by CT scan or MRI - Bone lesions - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Abdominal masses not confirmed and followed by imaging techniques - Cystic lesions - No active CNS metastases (treated CNS metastases stable for more than 8 weeks are allowed) - 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 - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8.5 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal - No inability to take oral or nasogastric medication - No requirement for IV alimentation - No active peptic ulcer disease Ophthalmic - No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjögren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (Schirmer test or similar tear production test) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Sub-dermal implants and condoms are not considered acceptable forms of contraception - No other invasive non-breast malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy - At least 2 weeks since prior immunotherapy - No prior cetuximab Chemotherapy - At least 2 weeks since prior chemotherapy and recovered - No more than 1 prior chemotherapy regimen for metastatic disease - No more than 2 prior chemotherapy regimens total, including adjuvant therapy Endocrine therapy - Prior hormonal therapy allowed in metastatic and/or adjuvant setting Radiotherapy - At least 2 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow - No prior strontium chloride Sr 89 Surgery - More than 4 weeks since prior major surgery - No prior surgical procedures affecting absorption Other - No prior epidermal growth factor receptor-targeting therapies (e.g., gefitinib or EKB-569) - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent antitumor therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephanThome, , Oncology Hematology West, P.C. - Omaha Bergan
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Oncology Hematology West, P.C. - Omaha Bergan *Recruiting*
Omaha, Nebraska, 68124
United States
Recruiting Stephan Thome 402-393-3110
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Spelsberg 507-284-2511
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Additional Information:
Study ID Numbers: CDR0000298778; NCCTG-N0234
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059852
Other Recurrent Breast Cancer Studies:
1. Radiolabeled Monoclonal Antibody Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
2. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
3. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
4. Erlotinib in Treating Women With Locally Advanced or 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:
Other recurrent breast cancer Clinical Trials
Other South Dakota Clinical Trials
Other Sioux Falls Clinical Trials
Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane
|
|
|
|
|
|
|
|
