Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic, Unresectable Pancreatic Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. 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 radiation therapy plus paclitaxel in treating patients who have nonmetastatic, unresectable pancreatic cancer.

Sex

All

Minimum age

18 Years

DISEASE CHARACTERISTICS: Histologically confirmed nonmetastatic, unresectable pancreatic adenocarcinoma No evidence of metastatic disease in the major viscera and no peritoneal seeding Residual disease after resection (R-1 or -2 micro- and macroscopic residual) eligible if measurable disease on the post operative CT or MRI scan Recurrent disease following radical surgery is eligible All malignant disease must be encompassable within a single irradiation field Must be a radiographically assessable disease CT with 5 mm cuts or spiral CT

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,800/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Biliary system stented Renal: Creatinine less than 3.0 mg/dL OR Creatinine clearance at least 40 mL/min Other: If patients have biliary or gastroduodenal obstruction, they must have drainage prior to starting chemoradiation Oral intake of at least 1,500 calories per day No significant infection or other coexistent medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior paclitaxel At least 4 weeks since prior gemcitabine No other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the planned field Surgery: See Disease Characteristics

• BACKGROUNDGarofalo MC, Winter K, Regine WF, et al.: Recursive partitioning analysis (RPA) of prognostic factors in six Radiation Therapy Oncology Group (RTOG) trials of chemoradiotherapy for unresectable pancreatic cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-144, S80-1, 2006.
• RESULTKonski AA, Winter K, Khor L, et al.: Over-expression of RIa subunit (RIas) of protein kinase A may be a marker for favorable pancreatic cancer: an analysis of patients treated on Radiation Therapy Oncology Group (RTOG) 98-12. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-148, 2006.
• RESULTRich T, Harris J, Abrams R, Erickson B, Doherty M, Paradelo J, Small W Jr, Safran H, Wanebo HJ. Phase II study of external irradiation and weekly paclitaxel for nonmetastatic, unresectable pancreatic cancer: RTOG-98-12. Am J Clin Oncol. 2004 Feb;27(1):51-6. doi: 10.1097/01.coc.0000046300.88847.bf. PMID 14758134
• RESULTRich T, Harris J, Abrams R, et al.: A phase II study of external irradiation and weekly paclitaxel for non-metastatic, unresectable pancreatic cancer: a preliminary report of RTOG protocol 98-12. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-51, 29-30, 2001.