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UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors Clinical research trials and UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors health trials take place in a lot of 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 potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors. UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "U" Clinical Trials Conditions > UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors  UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01, fluorouracil, and leucovorin in treating patients who have metastatic or unresectable solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of fluorouracil when given in combination with UCN-01 and leucovorin calcium in patients with metastatic or unresectable solid tumors. - Determine the clinical toxic effects of this regimen in these patients. - Determine the pharmacokinetics of these drugs in these patients. - Correlate, if possible, the pharmacokinetics of these drugs with clinical toxicity in these patients. - Assess the pharmacodynamic effects of these drugs in these patients. - Assess any clinical activity of this regimen in patients with measurable disease. OUTLINE: This is a dose-escalation study of fluorouracil (5-FU). Patients receive leucovorin calcium (CF) IV over 2 hours and 5-FU IV (at the midpoint of CF administration) on day 1, followed by UCN-01 IV over 36-72 hours, on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RPIID) is defined as the dose preceding the MTD. At least 6 additional patients are treated at the RPIID. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor that is metastatic or unresectable and for which no standard curative or palliative measures exist or are effective - No brain metastases or primary CNS malignancy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 3 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular - No known active coronary artery disease Pulmonary - No pulmonary dysfunction Other - HIV negative - No history of unusually severe and/or prolonged toxicity during prior therapy with fluorouracil (5-FU) or 5-FU prodrugs - No diabetes mellitus requiring insulin or oral hypoglycemic therapy - No ongoing or active infection requiring IV antibiotics - No other serious concurrent medical illness that would preclude study - No psychiatric illness or social situations that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy and recovered - No concurrent cytokines during the first course of therapy Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - No concurrent systemic corticosteroids Radiotherapy - At least 2 weeks since prior radiotherapy and recovered - No prior pulmonary or mediastinal radiation exceeding 40 Gy Surgery - Recovered from prior surgery Other - No other concurrent investigational agents - No concurrent cimetidine - No concurrent sorivudine or brivudine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanGrem, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Additional Information:
Study ID Numbers: CDR0000069478; NCI-NAVY-01-04,NCI-02-C-0222,NCI-5535
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042861
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
2. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
3. Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
4. UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
5. Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
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