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Title 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

IRB RTOG0848

CC 14-1113

Hospital Strongsville, Wooster

Stage Stage 3

Phase Phase 2, Phase 3

Disease Pancreas

Drug Erlotinib

Description

Primary Objectives

1. Ph II-R: To determine whether the addition of erlotinib to gemcitabine 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).
2. Ph III:To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after 5 cycles of gemcitabine based chemotherapy.

Secondary Objectives

1. 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.
2. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma.
3. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma.
4. To evaluate adverse events of adjuvant chemotherapy � radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy.
5. 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.
6. To determine if patients reporting low baseline fatigue, as measured by the FACITFatigue, predicts survival and to explore correlations between baseline fatigue, as measured by PROMIS, and survival.

Inclusion Criteria

1. 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).
2. Interval between definitive tumor-related surgery and 1st step registration between 21-70 days.
3. Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible. Pathologic reporting using the CAPS format is strongly encouraged
4. Age ≥ 18.
5. Zubrod performance status 0 or 1.
6. Complete history and physical examination including weight and Zubrod status within 31 days of study entry.
7. 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.
8. CBC/differential obtained within 21 days of registration on study, with adequate bone marrow function defined as follows:
   • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
   • Platelets ≥ 100,000 cells/mm³
   • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
9. Post resection serum CA19-9 ≤ 180 units/mL within 21 days of registration on study.
10. Patients must have:
    • Serum total bilirubin ≤ twice the institutional upper limit of normal within 21 days of registration on study.
    • Creatinine levels ≤ twice the institutional upper limit of normal within 21 days of registration on study.
    • SGOT must be ≤ 2.5 x the institutional upper limit of normal within 21 days of registration on study.
11. Negative serum pregnancy test for women of childbearing potential within 14 days of study registration.
12. Abdominal/pelvic 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 IV contrast can have MRI of the abdomen/pelvis instead.
13. Signed study-specific informed consent
14. Consultation, agreement, and documentation in the patient�s chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol.
15. Women of childbearing potential and male participants must practice adequate contraception.
16. Patients with active HIV infection are eligible if their CD4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of HAART is allowed.

Exclusion Criteria

1. 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 intraductal papillary mucinous neoplasms (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.
2. Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy.
3. Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable.
4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
5. 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.
6. 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
7. Pregnant or lactating women
8. Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
9. If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible.