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

• Status: Completed
• Trial end date: 2009-07-01
• 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. Combining radiation therapy with chemotherapy may kill more tumor cells.

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

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed unresectable adenocarcinoma of the pancreas

• No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin

• Prior subtotal resection or gross residual disease

• No microscopic residual disease only

• No metastatic disease outside of planned study radiotherapy field

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• AST no greater than 3 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to maintain adequate oral nutrition

• No significant infection

• No other medical condition that would preclude study

• No other malignancy within the past 5 years except non-melanoma skin cancer

• No significant nausea or vomiting

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior or concurrent biologic therapy

Chemotherapy:

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy that would overlap planned study radiotherapy fields

Surgery:

• See Disease Characteristics

• At least 21 days since prior laparotomy