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A Phase II-R and a Phase III Trial Evaluating Both *Erlotinib (PH II-R) and Chemoradiation (PH III) as Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma

Description

PRIMARY OBJECTIVES: I. To determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine (gemcitabine hydrochloride) adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). (Phase II-R) II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after 5 cycles of gemcitabine based chemotherapy. (Phase III) SECONDARY OBJECTIVES: I. To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 cycles of adjuvant chemotherapy. II. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma. III. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma. IV. To evaluate adverse events of adjuvant chemotherapy with or without radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy. V. To evaluate preoperative cross-sectional imaging of the primary head of pancreas adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present. VI. To determine if patients reporting low baseline fatigue, as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, predicts survival and to explore correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS), and survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride orally (PO) once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. (NOTE: Phase II-R erlotinib hydrochloride randomization completed, Arm 2 closed to accrual effective 2/19/2014) Patients with no disease progression after treatment in arm I or II are then stratified according to their first randomization treatment arm (arm I vs arm II) and randomized to 1 of 2 additional treatment arms (arm III or IV). ARM III: Patients receive 1 course of the same treatment that they receive in arm I or II. ARM IV: Patients receive 1 course of the same treatment that they receive in arm I or II. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice daily (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. After completion of study treatment, patients are followed up periodically.

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion Criteria:
  • Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible
  • The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins—bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)
  • Interval between definitive tumor-related surgery and 1st step registration between 21-70 days
  • Patients will be staged according to the 6th edition American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-3, N0-1, M-0 being eligible
  • Zubrod performance status 0 or 1
  • Complete history and physical examination including weight and Zubrod status within 31 days of study entry
  • Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Hemoglobin (Hgb) >= 8.0 g/dL (transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)
  • Post resection serum cancer antigen (CA)19-9 =< 180 units/mL within 21 days of registration on study
  • Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study
  • Creatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study
  • Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN within 21 days of registration on study
  • Negative serum pregnancy test for women of childbearing potential within 14 days of study registration
  • Abdominal/pelvic computed tomography (CT) scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within 31 days of registration on study; patients allergic to intravenous (IV) contrast can have magnetic resonance imaging (MRI) of the abdomen/pelvis instead
  • Signed study-specific informed consent
  • Consultation, agreement, and documentation in the patient's chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol
  • Women of childbearing potential and male participants must practice adequate contraception
  • Patients with active human immunodeficiency virus (HIV) infection are eligible if their cluster of differentiation (CD)4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed Exclusion Criteria:
  • Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas; patients with tumors that are largely IPMN with a minimal or minor component of invasive carcinoma are not eligible; patients with acinar carcinomas are not eligible; patients with IPMN's that contain some secondary (minor) foci of adenocarcinoma are also not eligible
  • Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
  • Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (patients with a previous history of carcinoma in situ are eligible)
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the 3 months of study registration
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Pregnant or lactating women
  • Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible

Sites

  • California

    • Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, 91505
    • City of Hope Medical Center, Duarte, California, 91010
    • Sharp Memorial Hospital, San Diego, California, 92123
    • UC San Diego Moores Cancer Center, La Jolla, California, 92093
    • Kaiser Permanente Radiation Oncology Cancer Treatment Center, Santa Clara, California, 95051
    • California Pacific Medical Center-Pacific Campus, San Francisco, California, 94118
    • Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, 95682
    • Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, 95687
    • Radiological Associates of Sacramento, Sacramento, California, 95815
    • Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, 95661
    • Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, 95603
  • Arizona

    • Mayo Clinic in Arizona, Scottsdale, Arizona, 85259
  • Idaho

    • Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho, 83301
    • Saint Luke's Mountain States Tumor Institute, Boise, Idaho, 83712
  • Oregon

    • Mid-Columbia Medical Center, The Dalles, Oregon, 97058
  • Texas

    • The Don and Sybil Harrington Cancer Center, Amarillo, Texas, 79106
    • M D Anderson Cancer Center, Houston, Texas, 77030
  • Washington

    • Cancer Care Northwest-North Spokane, Spokane, Washington, 99218
  • Kansas

    • Cancer Center of Kansas-Liberal, Liberal, Kansas, 67901
    • Cancer Center of Kansas - Pratt, Pratt, Kansas, 67124
    • Cancer Center of Kansas-Kingman, Kingman, Kansas, 67068
    • Cancer Center of Kansas - Salina, Salina, Kansas, 67401
    • Cancer Center of Kansas - Newton, Newton, Kansas, 67114
    • Cancer Center of Kansas-Independence, Independence, Kansas, 67301
    • Cancer Center of Kansas - Chanute, Chanute, Kansas, 66720
    • Cancer Center of Kansas - Parsons, Parsons, Kansas, 67357
    • Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, 66701
  • Nebraska

    • Good Samaritan Hospital, Kearney, Nebraska, 68847
  • Louisiana

    • Louisiana State University Health Sciences Center Shreveport, Shreveport, Louisiana, 71103
    • Ochsner Medical Center Jefferson, New Orleans, Louisiana, 70121
  • Minnesota

    • Mayo Clinic, Rochester, Minnesota, 55905
  • Illinois

    • Illinois CancerCare-Carthage, Carthage, Illinois, 62321
    • Illinois CancerCare-Macomb, Macomb, Illinois, 61455
    • Saint Anthony's Health, Alton, Illinois, 62002
    • Western Illinois Cancer Treatment Center, Galesburg, Illinois, 61401
    • Illinois CancerCare Galesburg, Galesburg, Illinois, 61401
    • Illinois CancerCare-Canton, Canton, Illinois, 61520
    • Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, 61443
    • Saint John's Hospital, Springfield, Illinois, 62702
    • Illinois CancerCare-Pekin, Pekin, Illinois, 61554
    • Illinois CancerCare-Peoria, Peoria, Illinois, 61615
    • Methodist Medical Center of Illinois, Peoria, Illinois, 61603
    • Illinois CancerCare-Princeton, Princeton, Illinois, 61356
    • Illinois CancerCare-Eureka, Eureka, Illinois, 61530
    • Illinois CancerCare-Bloomington, Bloomington, Illinois, 61701
    • Saint Joseph Medical Center, Bloomington, Illinois, 61701
    • Illinois CancerCare-Peru, Peru, Illinois, 61354
    • Valley Radiation Oncology, Peru, Illinois, 61354
    • Radiation Oncology of Northern Illinois, Ottawa, Illinois, 61350
    • Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, 61350
    • Carle Physician Group-Effingham, Effingham, Illinois, 62401
    • Saint Anthony Medical Center, Rockford, Illinois, 61108
    • Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, 61938
    • Rush-Copley Healthcare Center, Yorkville, Illinois, 60560
    • Carle Cancer Center, Urbana, Illinois, 61801
    • The Carle Foundation Hospital, Urbana, Illinois, 61801
    • Rush - Copley Medical Center, Aurora, Illinois, 60504
    • Cadence Cancer Center in Warrenville, Warrenville, Illinois, 60555
    • Edward Hospital/Cancer Center, Naperville, Illinois, 60540
    • Carle on Vermilion, Danville, Illinois, 61832
    • Loyola University Medical Center, Maywood, Illinois, 60153
    • Rush University Medical Center, Chicago, Illinois, 60612
    • Advocate Illinois Masonic Medical Center, Chicago, Illinois, 60657
    • University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637
  • Missouri

    • Siteman Cancer Center - Saint Peters, Saint Peters, Missouri, 63376
    • Barnes-Jewish West County Hospital, Saint Louis, Missouri, 63141
    • Washington University School of Medicine, Saint Louis, Missouri, 63110
    • Saint Francis Medical Center, Cape Girardeau, Missouri, 63703
  • Wisconsin

    • Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin, 54701
    • Sacred Heart Hospital, Eau Claire, Wisconsin, 54701
    • Marshfield Clinic-Rice Lake Center, Rice Lake, Wisconsin, 54868
    • Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin, 54729
    • Saint Joseph's Hospital, Marshfield, Wisconsin, 54449
    • Marshfield Clinic, Marshfield, Wisconsin, 54449
    • Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, 54494
    • Marshfield Clinic Cancer Care at Saint Michael's Hospital, Stevens Point, Wisconsin, 54481
    • Aspirus Regional Cancer Center, Wausau, Wisconsin, 54401
    • Marshfield Clinic-Wausau Center, Wausau, Wisconsin, 54401
    • Diagnostic and Treatment Center, Weston, Wisconsin, 54476
    • Marshfield Clinic - Weston Center, Weston, Wisconsin, 54476
    • Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, 54548
    • Marshfield Clinic at James Beck Cancer Center, Rhinelander, Wisconsin, 54501
    • Langlade Hospital and Cancer Center, Antigo, Wisconsin, 54409
    • Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226
    • Bellin Memorial Hospital, Green Bay, Wisconsin, 54301
  • Mississippi

    • University of Mississippi Medical Center, Jackson, Mississippi, 39216
    • Singing River Hospital, Pascagoula, Mississippi, 39581
  • Indiana

    • Woodland Cancer Care Center, Michigan City, Indiana, 46360
    • IU Health Goshen Center for Cancer Care, Goshen, Indiana, 46526
    • Reid Hospital and Health Care Services, Richmond, Indiana, 47374
  • Ohio

    • Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, 45220
    • Samaritan North Health Center, Dayton, Ohio, 45415
    • Good Samaritan Hospital - Dayton, Dayton, Ohio, 45406
    • Grandview Hospital, Dayton, Ohio, 45405
    • Upper Valley Medical Center, Troy, Ohio, 45373
    • Miami Valley Hospital, Dayton, Ohio, 45409
    • Kettering Medical Center, Kettering, Ohio, 45429
  • Kentucky

    • University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 40536
  • Georgia

    • Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, 30342
    • Emory University Hospital Midtown, Atlanta, Georgia, 30308
    • Emory University/Winship Cancer Institute, Atlanta, Georgia, 30322
  • Israel

    • Chaim Sheba Medical Center, Tel Hashomer, 52621
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