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Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical research trials and Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors. Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors clinical trial. Human subjects often get the best healthcare available for their Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors  Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors
Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Suspended
Sponsor(s): Mayo Clinic 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 and chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with irinotecan in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib and irinotecan in patients with advanced solid tumors that overexpress epidermal growth factor receptor. - Determine the dose-limiting toxicity of this regimen in these patients. - Evaluate the effect of this regimen on epidermal growth factor receptor phosphorylation in these patients. - Assess, preliminarily, any antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral erlotinib daily on days -6 to -1. Patients then receive oral erlotinib once daily and irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib and irinotecan 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. Additional patients are treated at the MTD. Patients are followed for 3 months. PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy that overexpresses epidermal growth factor receptor (EGFR) - Unresectable disease for which there is no known standard therapy that is potentially curative or definitely capable of extending life expectancy - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 3 times ULN (5 times ULN if liver metastases present) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No New York Heart Association class III or IV heart disease Gastrointestinal - No gastrointestinal tract disease resulting in an inability to take oral or nasogastric medication - No requirement for IV alimentation - No active peptic ulcer disease Ophthalmic - No abnormalities of the cornea (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 (e.g., Schirmer test or similar tear production test) Other - No other uncontrolled concurrent illness - No ongoing or active infection - No significant traumatic injury within the past 21 days - No seizure disorder - No psychiatric illness or social situation that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy or biologic therapy - No concurrent immunotherapy Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow - No concurrent radiotherapy Surgery - More than 3 weeks since prior major surgery - No prior surgical procedures affecting absorption Other - No prior EGFR-targeting therapy (e.g., gefitinib or EKB-569) - No other concurrent investigational therapy - No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine, or valproic acid) - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent enrollment on another study involving pharmacological agents for symptom control or therapeutic intent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryPitot, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000256910; NCI-5351,MAYO-MC0112
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045201
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
2. Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections
3. Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
4. Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
5. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors
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