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Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors Clinical research trials and Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors. Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors  Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
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. UCN-01 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and toxicity profile of fluorouracil with UCN-01 in patients with advanced or refractory solid tumors. II. Assess the clinical pharmacokinetics of this regimen and correlate with observed toxicities in these patients. III. Obtain preliminary data on the therapeutic activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of fluorouracil. Patients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients receive an initial dose of UCN-01 IV over 72 hours beginning on day 2 during course 1 and then maintenance UCN-01 IV over 36 hours beginning on day 2 during subsequent courses. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of fluorouracil 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 toxicity. PROJECTED ACCRUAL: Approximately 6-48 patients will be accrued for this study within approximately 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists - Measurable or evaluable disease - No CNS metastasis or primary CNS malignancy --Prior/Concurrent Therapy-- See Disease Characteristics Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered - Prior fluorouracil allowed Endocrine therapy: Not specified Radiotherapy: - No prior mediastinal radiotherapy - At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No concurrent anticonvulsant medications --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: - WBC greater than 3,500/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No history of coronary artery disease documented by prior myocardial infarction, angiography, or coronary-artery bypass grafting - No cardiac arrhythmias or congestive heart failure within the past 6 months - Stable atrial fibrillation on standard treatment allowed at discretion of investigator Pulmonary: DLCO at least 60% of predicted Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study - No active serious or uncontrolled infection - HIV negative - No diabetes - No other medical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchwartz, 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: CDR0000067256; MSKCC-9924,NCI-T99-0037
Study Start Date: July 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004059
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
2. Chemotherapy in Treating Patients With Advanced Solid Tumors
3. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
4. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
5. S-3304 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
Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
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