S9915 Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin

Criteria

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