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A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors Clinical research trials and A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors. A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors clinical trial. Subjects typically recieve the finest healthcare available for their A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors  A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors
A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors
For Condition: Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.
Details: Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. The duration of these treatments will be escalated in our Phase I study until patients are receiving therapy for 2 out of every 3 weeks. Standard Phase I drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, SN-38 will also be examined. We will also attempt to monitor the intracellular molecular effects of SN-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Recurrent or metastatic cancer, including lymphoma. No leukemia. No active CNS disease. Refractory to all effective therapy OR No effective therapy exists. Measurable disease not required. PRIOR/CONCURRENT THERAPY: Biologic Therapy: Greater than 4 weeks and recovered from immunotherapy. Chemotherapy: Greater than 4 weeks and recovered from chemotherapy. Previous therapy with irinotecan is permitted. Endocrine Therapy: Not specified. Radiotherapy: Greater than 4 weeks since radiotherapy. Surgery: Recovered from prior surgery. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: ECOG 0-2. Hematopoietic: AGC greater than 1,500. Platelets greater than 100,000. Hepatic: Bilirubin no greater than 1.5 mg/dL. AST no greater than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL. OTHER: HIV negative. No active infection requiring antibiotics. No concurrent medical illness that would interfere with chemotherapy. No pregnant or nursing women. Adequate contraception required of fertile patients. Imaging/exams for tumor measurement within 28 days prior to registration.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960013; 96-C-0013
Study Start Date: November 9, 1995
Record last reviewed: September 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001495
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4. Dose Determination of 5-Fluorouracil in Combination with Leucovorin and the Experimental Drug UCN-01 to Treat Cancer
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A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors
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