RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the pancreas stage II pancreatic cancer stage III pancreatic cancer	Drug: fluorouracil  Drug: gemcitabine  Drug: oxaliplatin  Procedure: chemotherapy  Procedure: radiation therapy  Procedure: radiosensitization	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the 1-year survival rate in patients with locally advanced, unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy, oxaliplatin, and fluorouracil followed by gemcitabine.

Secondary

• Determine overall survival, time to disease progression, and confirmed response rate in patients treated with this regimen.
• Determine toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 7-25 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Unresectable disease, including subtotal resection and gross residual disease
• Locally advanced disease
• No cystadenocarcinoma of the pancreas
• No pancreatic tumors of neuroendocrine origin
• No microscopic residual disease as only evidence of pancreatic cancer
• All disease must be encompassable within standard radiotherapy fields for pancreatic cancer
• No distant metastases (liver or lung metastases or peritoneal spread)
• No evidence of metastatic disease outside the planned radiotherapy field

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• AST ≤ 3 times ULN

Renal

• Creatinine ≤ 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 significant nausea or vomiting
• No other medical condition that would preclude study participation
• No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score < 7)
• No known allergy to platinum compounds

PRIOR CONCURRENT THERAPY: Biologic therapy

• No prior biologic therapy
• No concurrent biologic therapy
• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy that would overlap planned radiotherapy fields
• No other concurrent radiotherapy

Surgery

• See Disease Characteristics
• At least 21 days since prior laparotomy

Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Des Moines General Hospital, Des Moines,  Iowa,  50309,  United States; Recruiting
      John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines,  Iowa,  50316-2301,  United States; Recruiting
      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States; Recruiting
      Medical Oncology and Hematology Associates - West Des Moines, West Des Moines,  Iowa,  50266,  United States; Recruiting
      Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines,  Iowa,  50314,  United States; Recruiting
      Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines,  Iowa,  50314,  United States; Recruiting
Kansas
      Associates in Womens Health, Wichita,  Kansas,  67203,  United States; Recruiting
      Cancer Center of Kansas - Chanute, Chanute,  Kansas,  66720,  United States; Recruiting
      Cancer Center of Kansas - Dodge City, Dodge City,  Kansas,  67801,  United States; Recruiting
      Cancer Center of Kansas - Kingman, Kingman,  Kansas,  67068,  United States; Recruiting
      Cancer Center of Kansas - Newton, Newton,  Kansas,  67114,  United States; Recruiting
      Cancer Center of Kansas - Salina, Salina,  Kansas,  67401,  United States; Recruiting
      Cancer Center of Kansas - Wellington, Wellington,  Kansas,  67152,  United States; Recruiting
      Cancer Center of Kansas - Winfield, Winfield,  Kansas,  67156,  United States; Recruiting
      Cancer Center of Kansas, P.A. - Wichita, Wichita,  Kansas,  67214-3728,  United States; Recruiting
      Cancer Center of Kansas, P.A. - El Dorado, El Dorado,  Kansas,  67042,  United States; Recruiting
      Cancer Center of Kansas, P.A. - Parsons, Parsons,  Kansas,  67357,  United States; Recruiting
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
      Pratt Cancer Center of Kansas, Pratt,  Kansas,  67124,  United States; Recruiting
      Southwest Medical Center, Liberal,  Kansas,  67901,  United States; Recruiting
      Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita,  Kansas,  67214,  United States; Recruiting
South Dakota
      Avera McKennan Hospital and University Health Center, Sioux Falls,  South Dakota,  57105-1080,  United States; Recruiting
      Medical X-Ray Center, Sioux Falls,  South Dakota,  57105,  United States; Recruiting
      Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls,  South Dakota,  57104,  United States; Recruiting

Study chairs or principal investigators

George P. Kim, MD,  Study Chair,  Mayo Clinic - Jacksonville   
Michael G. Haddock, MD,  Mayo Clinic Cancer Center   
John W. Bollinger, MD,  Merit Care Clinic - Bemidji   

Study ID Numbers:  CDR0000391191; NCCTG-N0349; NCT00096070
Record last reviewed:  February 2005
Last Updated:  April 4, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00096070
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08