Assessment of growth-limiting events caused by 5-fluorouracil in mouse cells and in human cells.
R M Evans, J D Laskin, M T Hakala
https://pubmed.ncbi.nlm.nih.gov/6162543Completed
Phase 1
All Genders
ID00001579
A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors
Led by National Cancer Institute (NCI) · Updated on 2006-07-17
50
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Assay and time course of 5-fluorouracil incorporation into RNA of L1210/0 ascites cells in vivo.
C P Spears, J Shani, A H Shahinian...
https://pubmed.ncbi.nlm.nih.gov/2578605Time-dose relationships for 5-fluorouracil cytotoxicity against human epithelial cancer cells in vitro.
P M Calabro-Jones, J E Byfield, J F Ward...
https://pubmed.ncbi.nlm.nih.gov/7127282