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A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors Clinical research trials and A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors. A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors clinical trial. Participants frequently get the best healthcare available for their A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors  A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors
A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors
For Condition: Lymphoma,Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a dose escalation study. During the first period of this study, an initial pharmacological assessment of fluorouracil administered intravenously along with oral leucovorin calcium is made. Leucovorin calcium is given orally bid on days 1-3. Fluorouracil is given as a 24 hour infusion on day 2. After a 2 week rest period and resolution of any toxicities experienced during the first period of treatment, patients are given an escalating dose of fluorouracil with fixed doses of leucovorin calcium and ethynyluracil. Ethynyluracil and leucovorin calcium are given bid orally on days 1-3 of each week. Fluorouracil is given bid orally on day 2 of each week. Treatment is repeated for three weeks followed by a one week rest period. 3 to 6 patients are enrolled at each dose level. Dose escalation proceeds until the maximum tolerated dose (MTD) is determined. MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity.
Details: The primary purpose of this Phase I protocol is to develop an orally administered regimen of fluorouracil (5-FU) given with fixed doses of leucovorin (LV) and 776C85 (GW776), a mechanism-based inhibitor of dihydropryimidine dehydrogenase (DPD), the rate-limiting enzyme involved in the catabolism of 5-FU. In the presence of 776C85, 5-FU is cleared by renal mechanisms. The schedule employed is intended to mimic the pharmacologic profile associated with a 24 hour weekly continuous infusion of 5-FU without the need for an indwelling central venous catheter. The target population is adult cancer patients with solid tumors. The first week, each patient will receive a single dose of 5-FU given by 24 hour continuous IV infusion at its recommended Phase II dose with low-dose oral LV. In the third week, the patient will begin 776C85 (GW776) and LV PO on days 1, 2, 3 at fixed doses. Oral 5-FU will be given on day 2, and the dose will be escalated in successive cohorts of patients. Treatment will be repeated weekly for three weeks, followed by a one week break. The dose of 5-FU will be adjusted according to individual tolerance. Cohorts of three patients will be entered at each dose level of 5-FU, which will be escalated until dose-limiting toxicity is seen (guidelines are outlined in the following schema). Treatment will be continued indefinitely until evidence of disease progression, provided the patient is tolerating therapy and wishes to continue. Biochemical monitoring suggests that there is profound and sustained inhibition of DPD with a single dose of 20 mg PO 776C85 days 1-3 each week for three of four weeks. Once the MTD has been defined for the once daily dosing on days 1, 2, 3 schedule, a simplified schedule will be evaluated in which a single dose of 776C85 on day 1 in the evening, with oral leucovorin days 1 and 2, and 5-FU given day 2 as a single dose. Since the pharmaceutical company has decided to go with a combined tablet of eniluracil/5-FU for future studies, the new schedule will be oral leucovorin on days 1 & 2, with 776C85 and 5-FU both given day 2 as a single dose.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Histologically proven solid tumor that has failed standard therapy or for which no such therapy exists. Tumor may be locally advanced and unresectable, recurrent and/or metastatic. Lymphomas with minimal or no involvement of bone marrow are also eligible. No primary malignancies or metastatic disease of the CNS. No symptomatic pre-existing peripheral neuropathy. PRIOR/CURRENT THERAPY: BIOLOGIC THERAPY: No immunotherapy within past 4 weeks. Recovered from toxic effects. CHEMOTHERAPY: No chemotherapy within past 4 weeks (6 weeks for nitrosoureas). No mitomycin within past 12 weeks. Recovered from toxic effects. ENDOCRINE THERAPY: Not specified. RADIOTHERAPY: No radiotherapy within past 2 weeks (8 weeks for strontium therapy). Recovered from toxic effects. SURGERY: Recovered from prior surgery. OTHER: No concurrent cimetidine. PATIENT CHARACTERISTICS: AGE: 18 and over. PERFORMANCE STATUS: ECOG 0-2. LIFE EXPECTANCY: Not specified. HEMATOPOIETIC: Absolute granulocyte count at least 2000/mm(3); Platelet count at least 100,000/mm(3). HEPATIC: Bilirubin no greater than 2 times upper normal limit; SGOT/SGPT no greater than 4 times upper normal limit. RENAL: Creatinine no greater than 1.6 mg/dL; Creatinine clearance greater than 55 mL/min. OTHER: Not pregnant or nursing. Fertile patients must use effective contraception. Not HIV positive. No active infections requiring intravenous antibiotic therapy. No other serious concurrent illness. No evidence of hemolytic uremic syndrome.
Total Enrollment: 50
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970136; 97-C-0136
Study Start Date: June 19, 1997
Record last reviewed: May 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001579
Other Lymphoma Studies:
1. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
2. Combination Chemotherapy in Treating Patients With Lymphoma
3. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
4. Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer
5. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
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A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors
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