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

Status: Recruiting
Phase: Phase 3
Diagnosis: Radiation Oncology, Pancreatic Cancer
NCT ID: NCT01013649 (View complete trial on
DFCI Protocol ID: 12-055


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


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Jennifer Wo, MD, Massachusetts General Hospital

Site-responsible Investigators:
Harvey Mamon, MD, PhD, Brigham and Women's Hospital

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed primary adenocarcinoma of the pancreatic head, neck, or uncinate process - Intraductal papillary mucinous neoplasm or invasive adenocarcinoma allowed - No non-adenocarcinoma, adenosquamous carcinoma, islet cell (neuroendocrine) tumor, cystadenoma, cystadenocarcinoma, carcinoid tumor, duodenal carcinoma, distal bile duct tumor, or ampullary carcinoma - Pathologic stage T1-3, N0-1, M0 disease according to AJCC 6th edition - 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 - Operative report must contain a statement from the surgeon explicitly detailing that a total gross excision of the primary tumor was achieved - Pathology report must include documentation of margin status, size of the tumor, and status of the 3 major surgical margins (bile duct, pancreatic parenchyma, and retroperitoneal [uncinate]) - Post-resection serum CA19-9 ≤ 180 IU/L - Tumor tissue block and peripheral blood samples must be submitted to the study's central tumor bank for correlative studies - No recurrent pancreatic cancer PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) - Serum total bilirubin ≤ 2 times upper limit of normal (ULN) - Creatinine ≤ 2 times ULN - SGOT ≤ 2.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - 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 - 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 - No other invasive malignancies within the past 2 years except for nonmelanomatous skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior systemic chemotherapy for pancreatic cancer - Prior chemotherapy for a different cancer allowed - No prior total pancreatectomy, distal pancreatectomy, or central pancreatectomy - No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields - Concurrent highly active antiretroviral treatment (HAART) allowed
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