|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00001579 |
|
Date of registration:
|
03/11/1999 |
|
Primary sponsor: |
|
|
Public title:
|
A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors
|
|
Scientific title:
|
A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors |
|
Date of first enrolment:
|
June 1997 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00001579 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety Study, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion 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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Lymphoma
|
|
Neoplasms
|
|
Intervention(s)
|
|
Drug: 5-Fluorouracil
|
|
Drug: Ethynyluracil
|
|
Drug: Leucovorin
|
|
Secondary ID(s)
|
|
97-C-0136
|
|
970136
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|