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Irinotecan Plus ICI D1694 in Treating Patients With Advanced 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 Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors Clinical research trials and Irinotecan Plus ICI D1694 in Treating Patients With Advanced 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 Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors. Irinotecan Plus ICI D1694 in Treating Patients With Advanced 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 Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors clinical trial. Subjects typically recieve the finest healthcare available for their Irinotecan Plus ICI D1694 in Treating Patients With Advanced 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 > "I" Clinical Trials Conditions > Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors  Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Pennsylvania Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating patients with advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of ICI D1694 (TDX) when given with irinotecan (CPT-11) every 3 weeks in patients with advanced solid malignancies. II. Describe the pharmacokinetics of TDX and CPT-11 when given in combination. III. Investigate the relationship between topoisomerase I expression in peripheral mononuclear cells and myelosuppression and/or gastrointestinal toxicity. IV. Investigate the effect of CPT-11 on thymidylate synthase expression in tumor. PROTOCOL OUTLINE: This is a dose-escalating study to determine the maximum tolerated dose (MTD) of ICI D1694 (TDX) given in combination with irinotecan. Irinotecan is given intravenously on day 1 and ICI D1694 intravenously on day 2. Treatment is repeated every 3 weeks until disease progression or unacceptable toxicity intervenes. Cohorts of 3-6 patients receive escalated doses of TDX until the MTD is defined; an additional 10-12 patients will be entered at the MTD to confirm this as a recommended phase II dose. PROJECTED ACCRUAL: 30-35 patients will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed solid tumor for which no effective therapy exists - Measurable or evaluable disease --Prior/Concurrent Therapy-- - At least 3 weeks since chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered; At least 3 weeks since radiotherapy and recovered --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0 or 1 - Hematopoietic: WBC at least 3,000 AGC at least 1,500; Platelets at least 100,000 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST/ALT no greater than 5 times normal - Renal: Creatinine no greater than 1.5 mg/dL - Metabolic: Glucose no greater than 200 mg/dL; Electrolytes within 10% normal - Other: No active infection that contraindicates entry; No significant medical problem that contraindicates entry; Effective contraception required of fertile patients; Able and willing to participate in pharmacokinetic sampling
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterO'Dwyer, Study Chair, University of Pennsylvania Cancer Center
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: CDR0000065242; UPCC-T96-0063,NCI-T96-0063O,JMC-T96-0063
Study Start Date: April 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002902
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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2. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
3. Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors
4. Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors
5. Lidocaine Patch in Treating Cancer Patients with Neuropathic Pain After Surgery
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Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
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