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A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients Clinical research trials and A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients. A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients clinical trial. Participants typically obtain the most effective healthcare available for their A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients  A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients
A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients
For Condition: Lymphoma,Neoplasm,Neoplasm Metastasis
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The primary objective of this protocol is to determine the clinical toxicities associated with administering sequential gemcitabine (dFdC) as a 30 minute infusion followed by a continuous infusion of fluorouracil (FUra) over 24 hour with low dose oral leucovorin (LV) weekly for two weeks out of three, and to identify appropriate doses of dFdC and FUra for future studies.
Details: The primary objective of this protocol is to determine the clinical toxicities associated with administering sequential gemcitabine (dFdC) as a 30 min infusion followed by a continuous infusion of Fluorouracil (FUra) over 24 hr with low dose oral Leucovorin (LV) weekly for two weeks out of three, and to identify appropriate doses of dFdC and FUra for future studies. This trial will be conducted in three parts. In part 1, the initial dose level will employ dFdC at 75% of its recommended dose as a single agent (750 mg/m(2)), FUra at approximately 50% of its recommended dose as a weekly 24 hr infusion (1150 mg/m(2)), and low-dose leucovorin for 2 weeks out of 3. In all stages of the protocol, to ensure tolerability, the patient will receive an initial cycle of dFdC alone. If tolerated, FUra will be added cycle 2. If the gemcitabine dose is not tolerated, the dose of dFdC will be decreased by one or two dose levels as outlined below, and a second cycle of dFdC alone will be given. FUra will be added the subsequent cycle. The dose of FUra will be escalated in 25% increments in cohorts of three patients up to a planned dose of 2250 mg/m(2). If dose-limiting toxicity is not observed at 2250 mg/m(2), then in the second part of the protocol, the dose of dFdC will be escalated in 20% increments. Once the maximally tolerated dose of dFdC is determined, in the third part of the protocol, additional cohorts of patients will be treated with 5-FU increased in 20 % increments while the dFdC dose is held constant.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with cancer who have failed standard therapy for their disease or for whom no such therapy is available, including patients with locally advanced, but unresectable primary or recurrent solid tumors, or metastatic disease. Patients with lymphoma who have not had high-dose chemotherapy requiring autologous or allogeneic stem cell rescue are eligible. Patients with leukemia are not eligible. Measurable disease is not required. ECOG Performance Status of 0-2. PRIOR TREATMENT: The following criteria should be met: Greater than 4 weeks should have elapsed since prior chemotherapy or immunotherapy, and the patient should have recovered from the toxicities associated with such therapy. If prior mitomycin C or nitrosourea therapy has been given, at least 6 weeks should have elapsed. If prior suramin therapy has been given, at least three months should have elapsed. At least two weeks (less than or equal to 20% of bone marrow reserve) or four weeks (greater than or equal to 21% of bone marrow reserve) should have elapsed since any radiotherapy, and the patient should have recovered from the toxicity associated with such therapy. If a recent surgical procedure has been performed, the patient should have recovered from the surgery prior to entering this trial. Patients should have an absolute granulocyte count greater than or equal to 2000/microliter and a platelet count greater than or equal to 100,000/microliter. Patients should have adequate hepatic and renal function as indicated by a serum bilirubin less than or equal to 2.0 mg/dl, hepatic transaminase levels less than 6 times the upper limit of normal, and a serum creatinine less than or equal to 2.0 mg/dl. Age greater than or equal to 18 years. Signed Informed Consent: The patient must be aware of the neoplastic nature of his/her disease and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts. EXCLUSION CRITERIA: Patients failing prior dFdC are not eligible. Pregnant women and nursing mothers are not eligible. Eligible patients of reproductive potential should use adequate contraception (applicable to both genders). No serious concurrent medical illness which would jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety. Patients should not enter this study until the cimetidine is discontinued. Ranitidine or another class of anti-ulcer agents can be substituted for cimetidine if necessary. Patients with active infections requiring intravenous antibiotic therapy are not eligible until the infection has cleared. Patients who are HIV antibody positive are ineligible. Patients with CNS metastatic disease or primary CNS malignancies are ineligible.
Total Enrollment: 108
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980143; 98-C-0143
Study Start Date: July 30, 1998
Record last reviewed: July 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001706
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A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients
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