Clinical trial · Interventional
S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach
NCT00004233CI-TRIAL-00005269completedPhase 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. 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| triacetyluridine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-FU, Leucovorin and PN-401
- description
- 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.
- interventionNames
- Drug: fluorouracil
- Drug: leucovorin calcium
- Drug: triacetyluridine
Primary outcomes (1)
- measure
- Six month survival
- timeFrame
- six months after registration
Secondary outcomes (1)
- measure
- evaluate quantitative and qualitative toxicities
- timeFrame
- three years at most
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction * No known brain metastases * Negative brain imaging required for neurologic signs and symptoms PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present) Renal: * Creatinine no greater than ULN Other: * Not pregnant or nursing * Fertile patients must use effective contraception * Must be able to swallow oral medication * No AIDS syndrome or HIV-associated complex * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy * No concurrent biologic therapy Chemotherapy: * No prior chemotherapy for advanced or metastatic gastric cancer * At least 6 months since prior chemotherapy as adjuvant or radiation sensitizer Endocrine therapy: * Not specified Radiotherapy: * At least 1 month since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * At least 3 weeks since prior major surgical resection of intra-abdominal organs and recovered
References
Publications (1)
- RESULTDoroshow JH, McCoy S, Macdonald JS, Issell BF, Patel T, Cobb PW, Yost KJ, Abbruzzese JL. Phase II trial of PN401, 5-FU, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach: a Southwest Oncology Group study. Invest New Drugs. 2006 Nov;24(6):537-42. doi: 10.1007/s10637-006-9244-8. PMID 16832602