A Phase 2 interventional study of fluorouracil and leucovorin calcium in Esophageal Cancer and Gastric Cancer, sponsored by SWOG Cancer Research Network. Completed at 97 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-25.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and leucovorin in treating patients who have unresectable, locally advanced, or metastatic cancer of the esophagus or stomach.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1, 8, 15, 22, 29, and 36. Patients receive oral triacetyluridine every 8 hours on days 1-3, 8-10, 15-17, 22-24, 29-31, and 36-38 beginning 8 hours after completion of each fluorouracil infusion. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's enrollment of 65 is close to the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
No known brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
PN401 is given on Days 1-3 weekly for six weeks; 5FU and leucovorin are given on Day 1 weekely for six weeks; followed by two weeks of rest. Continued in 8 week cycles until one of the criteria for removal from treatment is met.
Drug: fluorouracil · Drug: leucovorin calcium · Drug: triacetyluridine
Also known as: 5-FU
Also known as: LCV; leucovorin
Also known as: PN-401
Six month survival
Time frame: six months after registration
evaluate quantitative and qualitative toxicities
Time frame: three years at most
The record gives a start of Feb 2001, a primary completion of Jan 2007 and a completion of Jan 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluorouracil · Uridine triacetate
SWOG Cancer Research Network →