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Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors Clinical research trials and Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors. Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors clinical trial. Participants typically obtain the most effective healthcare available for their Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors  Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining irinotecan, oxaliplatin, and capecitabine in treating patients who have unresectablesolid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of irinotecan, oxaliplatin, and capecitabine in patients with unresectable solid tumors with or without the UGT1A1*28 genotype. - Determine the activity of this regimen in these patients. - Determine the toxicity profile, especially pertaining to hematologic and gastrointestinal toxicity, of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups according to UGT1A1*28 genotype. - Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 2-15. Courses repeat every 3 weeks. Cohorts of 3-6 patients receive escalating doses of irinotecan, oxaliplatin, and 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. Once the MTD is determined, an additional 6-10 patients (for a total of 12 patients) receive treatment at that dose. - Patients receive irinotecan, oxaliplatin, and capecitabine at the MTD as in group I. Cohorts of 3-6 patients receive escalating doses of irinotecan (beginning at the MTD determined in group I) until the MTD is determined. The MTD is defined as in group I. Once the MTD is determined, an additional 6-10 patients (for a total of 12 patients) receive treatment at that dose. Patients are followed at 3 months. PROJECTED ACCRUAL: A total of 24-86 patients (12-46 for group I and 12-40 for group II) will be accrued for this study within approximately 6-23 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy - Unresectable disease - Willing to provide biologic specimens to determine UGT1A1*28 polymorphism status - No CNS metastases - Prior CNS metastases allowed provided patient was treated with surgery and/or radiotherapy and is stable for more than 8 weeks 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 upper limit of normal (ULN) - AST no greater than 3 times ULN (5 times ULN if there is liver involvement) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergy to platinum compounds, irinotecan, or to antiemetics or antidiarrheals appropriate for administration with study therapy - No uncontrolled infection - No seizure disorder - No peripheral neuropathy grade 2 or greater PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy - No concurrent immunotherapy - No concurrent prophylactic colony-stimulating factor therapy Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of the bone marrow - No concurrent radiotherapy Surgery - See Disease Characteristics Other - No other concurrent investigational therapy - No concurrent sorivudine, brivudine, lamivudine, or stavudine - No concurrent enrollment in any other study involving a pharmacologic agent for symptom control or therapeutic intent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MathewGoetz, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Mathew Goetz 507-284-2511
Additional Information:
Study ID Numbers: CDR0000344367; MAYO-MC0311,NCI-6240
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074321
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Darbepoetin Alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
2. Interleukin-12 in Treating Patients With Advanced Cancer
3. Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
4. KRN7000 in Treating Patients With Solid Tumors
5. Nitrocamptothecin Plus Etoposide 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
Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
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