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Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer 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 Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer Clinical research trials and Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer 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 Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer. Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer 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 Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer clinical trial. Subjects frequently get the best healthcare possible for their Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer 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.
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Home > "E" Clinical Trials Conditions > Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer  Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
For Condition: recurrent breast cancer,Male Breast Cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer.
Details: OBJECTIVES: - Determine the antitumor effects of erlotinib and docetaxel, in terms of objective response, stabilization of disease, and progression-free survival, in patients with stage IV or recurrent breast cancer. - Determine time to tumor progression in patients treated with this regimen. - Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib. OUTLINE: Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1. Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression. Patients are followed for survival. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IV or recurrent adenocarcinoma of the breast - Measurable disease - Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel - Stable brain metastases 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 OR - Karnofsky 60-100% Life expectancy - More than 6 months Hematopoietic - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Hemoglobin at least 8 g/dL Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min - No clinically significant proteinuria - No significant impairment of renal function Cardiovascular - No New York Heart Association class III or IV heart disease - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No inadequately controlled hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80 - No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer - No ongoing or active infection - No peripheral neuropathy greater than grade 1 - No other concurrent uncontrolled medical condition that would preclude study participation - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Prior trastuzumab (Herceptin) allowed Chemotherapy - See Disease Characteristics - No prior chemotherapy for recurrent or metastatic disease - Prior adjuvant chemotherapy allowed Endocrine therapy - Prior hormonal therapy allowed Radiotherapy - Not specified Surgery - Not specified Other - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BethOvermoyer, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Beth Overmoyer 216-844-3862
Additional Information:
Study ID Numbers: CDR0000270200; CWRU-070214,CWRU-1102
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054275
Other Male Breast Cancer Studies:
1. Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
2. Radiolabeled SMT-487 in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer
3. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
4. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
5. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
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Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
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