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Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors Clinical research trials and Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors. Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors clinical trial. Subjects frequently get the best healthcare possible for their Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors  Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors
Nitrocamptothecin Plus Etoposide 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) , H. Lee Moffitt Cancer Center and Research Institute
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 nitrocamptothecin plus etoposide in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and safety of nitrocamptothecin when administered with etoposide in patients with advanced solid tumors. II. Determine the changes in expression and activity of topoisomerase I and II which occur during administration of this treatment regimen in these patients. III. Determine the plasma pharmacokinetics of this treatment regimen in these patients. IV. Compare the hematologic and nonhematologic toxicities with this treatment regimen in patients 70 years of age and older versus patients younger than 70 years of age. PROTOCOL OUTLINE: This is a dose escalation study of nitrocamptothecin. Patients receive oral nitrocamptothecin on days 1-3 and oral etoposide on days 4-5 each week. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of nitrocamptothecin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 4 weeks until toxicities resolve. PROJECTED ACCRUAL: Approximately 40-60 patients will be accrued for this study over 18 to 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed nonhematologic malignancy refractory to available therapies or for which no curative therapy exists - Measurable or evaluable disease - No active brain metastases, including evidence of cerebral edema by CT scan or MRI, progression from a prior imaging study, or any requirement for steroids or clinical symptoms of/from brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy; No concurrent colony stimulating factors (e.g., filgrastim (G-CSF) or sargramostim (GM-CSF)) - Chemotherapy: No prior topoisomerase I inhibitors (e.g., nitrocamptothecin, aminocamptothecin, irinotecan, or topotecan); At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas, mitomycin, or carboplatin); No other concurrent chemotherapy - Endocrine therapy: See Disease Characteristics; At least 4 weeks since prior hormonal therapy No concurrent hormonal anticancer therapy - Radiotherapy: At least 4 weeks since prior radiotherapy involving at least 30% of the bone marrow; No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent experimental anticancer medication --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL; ALT and AST less than 2 times upper limit of normal (ULN) (unless clearly related to hepatic metastases) - Renal: Creatinine less than 1.5 times ULN - Other: No other serious uncontrolled medical disorder or active infection that would preclude study; No dementia or altered mental status that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 10 weeks after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielSullivan, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000068063; MCC-12177,NCI-G00-1821
Study Start Date: June 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006047
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors
2. LY293111 in Treating Patients With Advanced Solid Tumors
3. Ro 31-7453 in Treating Patients With Metastatic Solid Tumors
4. Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
5. S-3304 in Treating Patients With Advanced Solid Tumors
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Other unspecified adult solid tumor, protocol specific Clinical Trials
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Nitrocamptothecin Plus Etoposide in Treating Patients With Advanced Solid Tumors
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