NCT00004233
S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
PHASE2
COMPLETED
NCT00004233
INTERVENTIONAL
A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach
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.
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
Esophageal Cancer
Gastric Cancer
- TREATMENT
-
- Type: DRUG
- Name: fluorouracil
- Description:
- Arm Group Labels: 5-FU, Leucovorin and PN-401
-
- Type: DRUG
- Name: leucovorin calcium
- Description:
- Arm Group Labels: 5-FU, Leucovorin and PN-401
-
- Type: DRUG
- Name: triacetyluridine
- Description:
- Arm Group Labels: 5-FU, Leucovorin and PN-401
- SWOG Cancer Research Network