Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy in treating patients with locally advanced upper gastrointestinal cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of any of the following upper gastrointestinal malignancies:

• Localized pancreatic adenocarcinoma

• Stage I, II, or III disease

• Parapancreatic node involvement and locally recurrent disease allowed

• Locally advanced biliary, gallbladder, or ampullary adenocarcinoma

• Stage II, III, or locally recurrent disease

• Histologically confirmed locally advanced gastric adenocarcinoma

• T3, T4, or node positive OR locally recurrent disease

• Histologically confirmed locally advanced duodenal cancer

• Stage II or III disease

• Locally advanced, but unresectable cancers may be included on protocol if appropriate for intraoperative radiotherapy (IORT)

• Other histologies may be considered for this protocol except for lymphoma, sarcoma, or neuroendocrine tumors

• Patients with evidence of metastatic disease are eligible if there is significant local disease warranting surgery and IORT

PATIENT CHARACTERISTICS:

• Karnofsky performance status > 60%

• Life expectancy > 4 months

• Absolute neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Serum creatinine < 2.0 mg/dL

• ALT < 3 x normal

• Bilirubin < 2 x normal

• Must be able to give voluntary informed consent

• No severe intercurrent illness that would make the patient inappropriate for laparotomy or otherwise inappropriate for treatment on protocol

• Prior history of malignancy allowed

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C)

• Prior gemcitabine hydrochloride allowed