Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer

OBJECTIVES:

• Determine the time to progression, local control, and survival of patients with locally advanced, unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy.

OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks.

Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced pancreatic cancer
• Regional (peri-pancreatic) lymph node involvement allowed
• Clinically or surgically staged and considered unresectable or inoperable

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 6 months

Hematopoietic:

• Granulocyte count at least 1,500/mm3
• Hemoglobin at least 10 g/dL
• Platelet count at least 100,000/mm3

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Not pregnant
• Fertile patients must use effective contraception
• No other concurrent or prior malignancy within the past 2 years except nonmelanoma skin cancer or in situ carcinoma of the cervix or breast
• No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival to less than 2 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent anticancer immunotherapy

Chemotherapy:

• No prior chemotherapy
• No other concurrent anticancer chemotherapy

Endocrine therapy:

• No concurrent anticancer hormonal therapy

Radiotherapy:

• No prior abdominal-pelvic radiotherapy
• No other concurrent anticancer radiotherapy

Surgery:

• See Disease Characteristics
• At least 3 weeks since prior open abdominal surgery
• More than 10 days since prior laparoscopy

Other:

• No other concurrent investigational drug
• No concurrent participation in other clinical study