Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery

April 09, 2010
Pancreatic Cancer
Alexander Hantel, MD

Naperville, Plainfield

This randomized phase III trial is studying gemcitabine hydrochloride and erlotinib hydrochloride to see how well they work compared with gemcitabine hydrochloride alone followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

Sponsor: SWOG (formerly the Southwest Oncology Group)

  • Histologically confirmed primary adenocarcinoma of the pancreatic head, neck, or uncinate process
  • Pathologic stage T1-3, N0-1, M0 disease
  • Has undergone a potentially curative resection (i.e., removal of all gross tumor) involving a classic(Whipple) or a pylorus preserving pancreaticoduodenectomy within the past 21-56 days
  • No recurrent pancreatic cancer
  • Suitable to receive study radiotherapy, as documented by a radiation oncologist
  • Active HIV infection allowed provided the CD4 count is = 499/mm^3 and the viral load is = 50 copies/mL
  • Total oral caloric intake = 1,500 calories/day
  • No significant nausea and vomiting
  • No prior systemic chemotherapy for pancreatic cancer
  • No other invasive malignancies within the past 2 years except for nonmelanomatous skin cancer or carcinoma in situ
  • None of the following severe active comorbidities that would preclude study therapy:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 3 months
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy


Accepting Participants
Kathy Seymour, BSN