• Median overall survival [ Designated as safety issue: No ]
  

• 1- and 2-year survival rate [ Designated as safety issue: No ]
  
• Median recurrence-free survival following pancreaticoduodenectomy [ Designated as safety issue: No ]
  
• Clinical response rate to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
  
• Pathologic response rate to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
  
• Biochemical response rate (CA 19-9 tumor marker) to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
  
• Surgical completion rate and complication rate following induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• To assess the median overall survival of patients with resectable, localized adenocarcinoma of the pancreas treated with induction chemotherapy comprising gemcitabine hydrochloride, docetaxel, and capecitabine and neoadjuvant chemoradiotherapy comprising capecitabine, oxaliplatin, and intensity-modulated radiotherapy followed by surgical resection and adjuvant chemotherapy comprising gemcitabine hydrochloride and oxaliplatin.

Secondary

• To determine the 1- and 2-year survival rate in patients treated with this regimen.
• To determine the median recurrence-free survival following pancreaticoduodenectomy.
• To determine the clinical response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
• To determine the pathologic response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
• To determine the CA 19-9 tumor marker response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
• To determine the surgical completion rate and complication rate following induction chemotherapy and neoadjuvant chemoradiotherapy.
• To determine the frequency and severity of toxicities associated with this regimen.

OUTLINE: This is a multicenter study.

• Induction chemotherapy: Patients receive gemcitabine hydrochloride IV over 75 minutes and docetaxel IV over 30 minutes on days 4 and 11. Patients also receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
• Neoadjuvant chemoradiotherapy: Beginning no more than 14 days after completion of induction chemotherapy, patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Patients also undergo intensity-modulated radiotherapy daily on days 1-5 and 8-12 (total of 10 fractions).
• Surgical resection: Approximately 2-6 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo pancreaticoduodenectomy or "Whipple" procedure with or without preservation of the pylorus and proximal duodenum or a distal pancreatectomy with or without splenectomy.
• Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gemcitabine hydrochloride alone IV over 100 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

  • Localized disease (T1-T3, N0-N1, M0 disease) as determined by helical multi-phase CT scan and/or endoscopic ultrasound according to published guidelines (AJCC 6th Ed.)

  • Resectable or borderline resectable disease as determined by the treating surgeon and published guidelines (National Comprehensive Cancer Network v2.2006)

    • No permanently unresectable adenocarcinoma of the pancreas

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Leukocyte count ≥ 3,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin normal
• AST/ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 1.5 times ULN if alkaline phosphatase > 2.5 times ULN)
• Creatinine ≤ 2.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to swallow and retain oral medication
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine hydrochloride, docetaxel, capecitabine, oxaliplatin, or other agents used in the study

• No concurrent uncontrolled illness including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

• No prior therapy for pancreatic cancer, including chemotherapy and radiotherapy
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy