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

• Status: Completed
• Trial end date: 2003-08-29
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

• 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; Irinotecan

Criteria

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