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:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:November 17, 2009

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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

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.

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 based chemotherapy or non-gemcitabine based chemotherapy such as modified
fluorouracil-leucovorin-irinotecan-oxaliplatin regimen (FOLFIRINOX) further enhances survival
for such patients who are without evidence of progressive disease after 5 months of adjuvant
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 months 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 without disease progression after treatment in arm I or II are randomized
to 1 of 2 additional treatment arms (arm III or IV).

ARM I: Patients receive either gemcitabine hydrochloride or allowable combination
chemotherapy per standard of care for 5 months.

ARM II (closed to accrual 4/2/14): Patients receive gemcitabine hydrochloride intravenously
(IV) over 30 minutes on days 1, 8, and 15 and erlotinib hydrochloride orally (PO) once daily
on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease
progression or unacceptable toxicity.

ARM III: Patients receive the same treatment as in arm I for 1 month.

ARM IV: Patients receive the same treatment as in arm I for 1 month. 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.

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
We found this trial at
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Burbank, California
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Burbank, CA
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1501 Trousdale Drive
Burlingame, California 94010
Principal Investigator: Christopher U. Jones
Phone: 916-537-5237
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Burlingame, CA
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Burlington, Massachusetts 01805
Principal Investigator: Keith E. Stuart
Phone: 781-744-8027
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Burlington, MA
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Burnsville, MN
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400 South Clark Street
Butte, Montana 59701
406-723-2500
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
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Butte, MT
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Camden, New Jersey 08103
Principal Investigator: Ashish B. Patel
Phone: 856-325-6757
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Camden, NJ
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Cameron Park, California 95682
Principal Investigator: Christopher U. Jones
Phone: 916-537-5237
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Cameron Park, CA
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360 Parrish Street
Canandaigua, New York 14424
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Canandaigua, NY
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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Canton, IL
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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Cape Girardeau, MO
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Principal Investigator: Bryan A. Faller
Phone: 573-651-5550
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Cape Girardeau, MO
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Carmichael, California 95608
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Carmichael, CA
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Carthage, IL
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6501 E 2nd St
Casper, Wyoming 82609
(307) 235-5433
Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
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Casper, WY
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20126 Stanton Ave
Castro Valley, California 94546
(510) 581-0556
East Bay Radiation Oncology Center East Bay Radiation Oncology Center offers superior medical and technical...
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Castro Valley, CA
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