SWOG clinical trial number
S9635

A Phase II Trial of 5-fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer

Closed
Phase
Accrual
49%
Published
Abbreviated Title
COLORECTAL
Activated
04/01/1998
Closed
09/15/2000
Participants

Research committees

Gastrointestinal Cancer

Treatment

5-Fluorouracil 776C85

Eligibility Criteria Expand/Collapse

Pts must have a cytologically or pathologically verified diagnosis of colorectal cancer. Pts must have dz which has progressed while on adjuvant therapy or within 12 months after completion of adjuvant therapy (adjuvant therapy must have been 5-FU based). Pts must have disseminated dz. Pts must have bidimensionally measurable dz. Pts must not have rcv'd tx for disseminated dz. Pts must be able to swallow and retain oral meds. Pts who require nutritional support via gastrostomy feeding tube or parenteral support are not elig. No concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for trx while on this study. Pts may have rc'd prior RT for colorectal cancer (to <= 25% of the bone marrow only) - pts must be at least 4 wks beyond the end of RT & recovered from all toxicities. Lesions w/in radiation port used to assess resp must have demonstrated clear progression following completion of RT. Pts may have had prior surgery - must be at least 2 wks beyond and recovered all effects. Pts may not have had resection of the stomach or small intestine. Concomitant use of fluocytosine is prohibited.

Publication Information Expand/Collapse

2002

Biochemical modulation of 5-fluorouacil through dihydropyrimidine dehydrogenase inhibition: a Southwest Oncology Group phase II trial of eniluracil and 5-fluorouracil in advanced resistant colorectal cancer.

CG Leichman;K Chansky;JS Macdonald;MA Doukas;GT Budd;JK Giguere;JL Abbruzzese Investigational New Drugs 20:419-424