Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas

• Status: Completed
• Trial end date: 2003-10-03
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy after surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.

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

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive adenocarcinoma of the pancreas

• Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or total pancreatectomy) within the past 2 months

• No clinical evidence of gross residual disease at time of surgery

• No focally positive margins (tumor at the margin)

• No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• More than 6 months

Hematopoietic:

• Granulocyte count greater than 1,500/mm3

• Hemoglobin greater than 10 g/dL

• Platelet count greater than 100,000/mm3

Hepatic:

• Bilirubin less than 2.0 mg/dL

Renal:

• Creatinine less than 2.0 mg/dL

Other:

• Able to maintain adequate oral nutrition

• Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study

• No other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast

• Non-metastatic prostate cancer allowed if more than 2 year survival likely

• No other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent routine growth factors

Chemotherapy:

• No prior chemotherapy for pancreatic cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior abdominal radiotherapy for pancreatic cancer

Surgery:

• See Disease Characteristics