Status:
COMPLETED
A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Neoplasms
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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. Le...
Detailed Description
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 inhibit...
Eligibility 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.
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
End Date :
March 1 2001
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00001579
Start Date
June 1 1997
End Date
March 1 2001
Last Update
July 17 2006
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892