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Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors Clinical research trials and Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors. Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors clinical trial. Participants frequently obtain the most expert healthcare available for their Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors  Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors
Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Institute for Drug Development , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and trastuzumab with paclitaxel may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining erlotinib and trastuzumab with paclitaxel in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the safety, quantitative and qualitative toxic effects, maximum tolerated dose, and dose-limiting toxic effects of erlotinib when combined with paclitaxel and trastuzumab (Herceptin) in patients with advanced solid tumors. - Determine the relevant pharmacokinetic interactions between these agents in these patients. - Determine, preliminarily, the antitumor activity of this regimen in these patients. OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of erlotinib. - Patients receive paclitaxel IV over 1 hour followed 30 minutes later by trastuzumab (Herceptin) IV over 30 minutes on days 1, 8, and 15 of each course. Patients also receive oral erlotinib once daily on days 3-28 of course 1 and on days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Continuous schedule: Once the MTD is determined using the intermittent schedule, an additional 12 patients are accrued to study the tolerability of a continuous schedule comprising paclitaxel and trastuzumab as above on days 1, 8, 15, and 22 and oral erlotinib once daily on days 3-28 during course 1 and on days 1-28 of subsequent courses using the same dose-escalation scheme as above. Courses repeat as above. Patients are followed every 30 days. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 10-13.3 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic solid tumor for which there are no effective standard treatment options - HER2 positive (1+ to 3+) - Tumor has a high likelihood of expressing epidermal growth factor receptor (EGFR) - No evidence of leptomeningeal disease or brain metastases unless previously treated, currently asymptomatic, and off both antiepileptics and dexamethasone - Patients with treated brain metastases are eligible if they are without any clinical change in their brain disease status for at least 4 weeks after whole brain irradiation PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver has tumor involvement) Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - LVEF more than 50% by radionuclide ventriculogram or MUGA scan - No significant cardiovascular disease - No prior congestive heart failure requiring therapy - No unstable angina pectoris - No myocardial infarction within the past 6 months Gastrointestinal - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation - Patients who are unable to swallow tablets and/or who have silicon-based G-tubes may dissolve the tablets in distilled water - No active peptic ulcer disease Other - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known or suspected hypersensitivity to paclitaxel - No prior allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or other study agents - No concurrent active infection - No other concurrent medical condition that would preclude study participation - No persistent grade 2 or greater neurotoxicity/neuropathy from any cause - No psychiatric disorders or altered mental status that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No other concurrent immunotherapy - No concurrent cytokine growth factors (e.g., colony-stimulating factors) Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent hormonal therapy except megestrol as an appetite stimulant or luteinizing hormone-releasing hormone agonists for prostate cancer Radiotherapy - See Disease Characteristics - No concurrent radiotherapy Surgery - No prior surgical procedures affecting absorption Other - No prior EGFR-targeting therapy - No other concurrent experimental medications or other specific antitumor therapy - No concurrent immunosuppressant therapy - No concurrent antiarrhythmic therapy for a ventricular arrhythmia
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricRowinsky, Study Chair, Cancer Therapy and Research Center
Cancer Therapy and Research Center *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Eric Rowinsky 210-616-5945
Institute for Drug Development *Recruiting*
San Antonio, Texas, 78245-3217
United States
Recruiting Johann de Bono 210-616-5970
Additional Information:
Study ID Numbers: CDR0000069472; CTRC-IDD-0135,NCI-5439
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042809
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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2. Chemotherapy in Treating Patients With Advanced Solid Tumors
3. VNP20009 in Treating Patients With Advanced Solid Tumors
4. Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
5. Lidocaine Patch in Treating Cancer Patients with Neuropathic Pain After Surgery
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Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors
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