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Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer Clinical research trials and Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer  Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
For Condition: stage 3B breast cancer,Male Breast Cancer,unspecified adult solid tumor, protocol specific,stage 3A breast cancer,inflammatory breast cancer
Status: Recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as docetaxel and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining tipifarnib with docetaxel and capecitabine may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of neoadjuvant tipifarnib combined with docetaxel and capecitabine in treating patients who have locally advanced or metastaticsolid tumors or stage IIIA or stage IIIB breast cancer.
Details: OBJECTIVES: Phase Ib - Determine the maximum tolerated dose and recommended dose of capecitabine in combination with docetaxel and tipifarnib in patients with locally advanced or metastatic solid tumors. Phase II - Determine the complete pathological and clinical response rate in patients with stage IIIA or IIIB breast cancer treated with this regimen. - Determine the toxicity of this regimen in these patients. - Determine disease-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of capecitabine. Patients in phase II are stratified according to type of breast cancer (inflammatory vs noninflammatory). - Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine 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. - Phase II: Patients receive oral tipifarnib twice daily for 6 days. Beginning at least 48 hours after completion of the initial dose of tipifarnib, patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine. Patients in phase Ib are followed at 3 months. Patients in phase II are followed every 4 months for up to 5 years. PROJECTED ACCRUAL: A total of 24-53 patients (9-18 for phase Ib and 15-35 for phase II) will be accrued for this study within 14-35 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Phase Ib - Histologically or cytologically confirmed solid tumor - Locally advanced or metastatic - No known standard therapy that is potentially curative or definitely capable of extending life expectancy - No history of metastatic brain disease within the past 6 months - Treated metastatic brain disease is allowed provided disease has been stable for more than 6 months and does not require concurrent steroids or anti-seizure medication Phase II - Histologically confirmed breast cancer - Stage IIIA or stage IIIB, including ipsilateral palpable supraclavicular lymph node(s) without other distant metastasis - Invasive disease confirmed by 1 of the following*: - Incisional biopsy - Punch biopsy (applicable for clinical T4b tumors) - Core needle (cutting needle) biopsies NOTE: *No positive cytology by fine-needle aspirate only - No distant metastatic disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic - Bilirubin no greater than upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - AST no greater than 2.5 times ULN Renal - Creatinine no greater than 1.25 times ULN OR - Creatinine clearance at least 50 mL/min Cardiovascular - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection requiring antibiotics - No diabetes - No symptomatic neurologic condition - No other uncontrolled serious medical condition - No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No history of hypersensitivity to intravenous paclitaxel or other medication containing Cremophor EL or polysorbate 80 as a carrier (phase Ib) PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy - More than 4 weeks since prior biologic therapy - No concurrent immunotherapy - No concurrent prophylactic filgrastim (G-CSF) Chemotherapy - More than 1 year since prior adjuvant docetaxel before metastatic relapse - More than 4 weeks since prior chemotherapy and recovered - No prior capecitabine AND docetaxel (in combination or as single agents) - Prior capecitabine OR docetaxel allowed - No other concurrent chemotherapy - No prior cytotoxic chemotherapy for breast cancer Endocrine therapy - Not specified Radiotherapy - More than 3 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow - No concurrent radiotherapy - No prior radiotherapy for breast cancer Surgery - More than 4 weeks since prior major surgery - No prior surgery (other than core or incisional biopsy for diagnostic purposes) for breast cancer Other - No other ancillary investigational therapy - No concurrent sorivudine or brivudine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PhilipPhilip, Study Chair, Barbara Ann Karmanos Cancer Institute
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting William Maples 904-953-7292
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Philip Philip 313-745-9155
Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Fitzroy Dawkins 202-806-9122
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paula Fracasso 314-454-8943
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Alex Adjei 507-284-2511
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Manuel Hidalgo 410-502-9746
Mayo Clinic Scottsdale *Recruiting*
Scottsdale, Arizona, 85259
United States
Recruiting Tom Fitch 480-301-9875
Additional Information:
Study ID Numbers: CDR0000331694; MAYO-MC0131,NCI-5599
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070252
Other Inflammatory Breast Cancer Studies:
1. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
2. Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
3. Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
4. Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Detecting Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II, Stage III, or Stage IV Breast Cancer
5. Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
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Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
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