Clinical trial · Interventional
SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil
A Phase II Trial of 5-Fluorouracil Plus 776C85 in Patients With Advanced Resistant Colorectal Cancer
NCT00003254CI-TRIAL-00006407completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ethynyluracil may help fluorouracil kill more cancer cells by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in treating patients with advanced colorectal cancer that has not responded to fluorouracil.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ethynyluracil | Drug | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 776C85 + 5-FU
- description
- 776C85, 10mg/m2/dose, PO, Days 1-28 (BID), q 5 wk; 5-FU, 1.0mg/m2/dose, PO, Days 1-28 (BID), q 5 wk.
- interventionNames
- Drug: ethynyluracil
- Drug: fluorouracil
Primary outcomes (1)
- measure
- Confirmed Response Rate
- timeFrame
- Once every 10 weeks until off treatment
- description
- To assess the confirmed response rate to 5-fluorouracil plus 776C85 in patients with measurable, disseminated colorectal cancer that has been demonstrated to be resistant to 5-fluorouracil.
Secondary outcomes (2)
- measure
- Progression and Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Histologically or cytologically proven metastatic colorectal cancer * Prior surgery required * No prior treatment for metastatic disease * Disease progression while on fluorouracil adjuvant therapy * Bidimensionally measurable disease * Age: Over 18 * Performance status: SWOG 0-2 * Hematopoietic: Platelet count at least 100,000/mm3, Absolute granulocyte count at least 1,500/mm3 * Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (no greater than 5 times ULN if liver involvement) * Renal: Creatinine clearance at least 50 mL/min * Other: Must be able to swallow and retain oral medications No nutritional support by gastrostomy feeding tube or parenteral support No intractable vomiting or nausea * Patients with history of prior malignancy must be currently disease free and off all therapy for that malignancy * Not pregnant or nursing Fertile patients must use effective contraception * Biologic therapy: No concurrent immunotherapy Chemotherapy; At least 3 weeks since prior chemotherapy and recovered; No concurrent flucytosine; No other concurrent chemotherapy * Endocrine therapy: No concurrent hormonal therapy * Radiotherapy: Prior adjuvant pelvic radiation or radiation to one area of recurrence allowed At least 4 weeks since prior radiotherapy and recovered Total area of bone marrow irradiation must not exceed 25% No concurrent radiotherapy * Surgery: At least 2 weeks since prior surgery for colorectal cancer and recovered No prior resection of the stomach or small intestine * Other: No other concurrent anticancer therapy
References
Publications (1)
- RESULTLeichman CG, Chansky K, Macdonald JS, Doukas MA, Budd GT, Giguere JK, Abbruzzese JL; Southwest Oncology Group. 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. Invest New Drugs. 2002 Nov;20(4):419-24. doi: 10.1023/a:1020662113061. PMID 12448660