RTOG 0848: A Phase III trial evaluating both Erlotinib and Chemoradiation as adjuvant treatment for patients with resected head of pancreas adenocarcinoma

Investigator: Lorraine Portelance

Institutional Protocol #: 20110584

National Clinical Trials Identifier: NCT01013649

Funding Agency/Sponsor: RTOG

Division: Cancer Center

Therapeutic Area: Pancreatic, Liver, and Related Cancers

Phase: Phase III

Enrolling Sites: University of Miami Hospital & Clinics, Jackson Memorial Hospital, UMD

Enrolling Since: 12/7/2011


Purpose/Abstract:


This randomized phase II-R/III trial studies 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
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, by stopping them from dividing, or by stopping them from
spreading. 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.




Eligibility 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)

- For patients who have not started their chemotherapy prior to registration, the
interval between definitive tumor-related surgery and 1st step registration must be
between 21-70 days; for patients entering on the study who have already received up
to 3 months of adjuvant chemotherapy as per the treating institution, the interval
between definitive tumor-related surgery and day one of adjuvant chemotherapy must be
between 21-77 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 (or within 31 days prior to day 1 of chemotherapy post-surgery
for those patients having started chemotherapy prior to first step registration)

- 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

- Complete blood count (CBC)/differential obtained within 21 days of registration on
study (or within 21 days prior to day 1 of chemotherapy post-surgery for those
patients having started chemotherapy prior to first step registration)

- 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 AND prior to any
systemic treatment

- Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within
21 days of registration on study (or within 21 days prior to day 1 of chemotherapy
post-surgery for those patients having started chemotherapy prior to first step
registration)

- Creatinine levels =< twice the institutional upper limit of normal within 21 days of
registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery
for those patients having started chemotherapy prior to first step registration)

- Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN
within 21 days of registration on study (or within 21 days prior to day 1 of
chemotherapy post-surgery for those patients having started chemotherapy prior to
first step registration)

- 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 (or within 31 days
prior to day 1 of chemo post-surgery for those patients having started chemotherapy
prior to first step registration); 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

- Patients entering on the study after pancreaticoduodenectomy, who have not already
started chemotherapy must not have had prior systemic chemotherapy for pancreas
cancer; note that prior chemotherapy for a different cancer is allowable; for
patients entering on the study who have already received up to 3 months of adjuvant
chemotherapy as per the treating institution, patients must not have received
adjuvant chemotherapy with agents other than gemcitabine, nab-paclitaxel,
oxaliplatin, fluoropyrimidine, or irinotecan for the current pancreatic cancer; 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 (or first day
of chemotherapy for patients having started chemotherapy prior to first step
registration); patients with a previous history of carcinoma in situ are eligible

- Severe, active co-morbidity, defined as follows per time points indicated below (or
per time points indicated below prior to the first day of chemotherapy for patients
having started chemotherapy prior to first step registration):

- 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


Gender: Both

Minimum Age: 18 Years

Maximum Age: N/A

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Cancer Center Studies
1-866-574-5124

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