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Irinotecan in Treating Patients With Advanced Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Irinotecan in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Irinotecan in Treating Patients With Advanced Solid Tumors Clinical research trials and Irinotecan in Treating Patients With Advanced Solid Tumors healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Irinotecan in Treating Patients With Advanced Solid Tumors. Irinotecan in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Irinotecan in Treating Patients With Advanced Solid Tumors clinical trial. Human subjects often receive the most effective healthcare possible for their Irinotecan in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Advanced Solid Tumors  Irinotecan in Treating Patients With Advanced Solid Tumors
Irinotecan in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and safety profile of oral irinotecan in patients with advanced solid tumors. II. Characterize the single and multiple dose pharmacokinetics of oral irinotecan and its metabolites, SN-38 and SN-38 glucuronide, in these patients. III. Document any antitumor activity in these patients treated with this regimen. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive oral irinotecan once daily for 14 days. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: Approximately 3-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven advanced solid tumor for which no curative therapy exists; No leukemias or lymphomas - Brain or leptomeningeal disease allowed only if prior irradiation of these lesions, no concurrent corticosteroids, and no clinical symptoms --Prior/Concurrent Therapy-- - At least 4 weeks since prior therapy for cancer and recovered - Biologic therapy: No concurrent immunotherapy; No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa - Chemotherapy: No prior nitrosoureas, mitomycin, or irinotecan; No prior high dose chemotherapy in support of peripheral blood stem cell transplantation; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: No prior irradiation of pelvis; No concurrent radiotherapy - Surgery: No prior gastrectomy or total colectomy - Other: At least 1 week since prior anticonvulsants; No other concurrent investigational drugs; No combination anticholinergic medications containing barbiturates (e.g., Donnatol) --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 150,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin no greater than 1.5 mg/dL regardless of liver tumor presence; SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if due to liver tumor) - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No uncontrolled high blood pressure; No unstable angina; No symptomatic congestive heart failure; No myocardial infarction within past 6 months; No serious uncontrolled cardiac arrhythmia - Gastrointestinal: No active inflammatory bowel disease; No significant bowel obstruction; No chronic malabsorption - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active infection; HIV negative; No AIDS; related illness No significant alcoholism or substance abuse; No severe medical or psychiatric illness that would preclude participation in study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonardSaltz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067246; MSKCC-98076,NCI-G99-1569,P-UPJOHN-976475155
Study Start Date: August 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004051
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
2. Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
3. CCI-779 in Treating Patients With Advanced Solid Tumors
4. Combination Chemotherapy In Treating Patients With Metastatic or Unresectable Solid Tumors
5. SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Irinotecan in Treating Patients With Advanced Solid Tumors
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