S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery



Status:Recruiting
Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:October 2015
End Date:October 2021

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A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and
oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and
paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients
with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as
fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and
paclitaxel albumin-stabilized nanoparticle formulation, 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. Giving more than one drug (combination chemotherapy) may kill
more tumor cells. It is not yet known whether combination chemotherapy is more effective than
gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before
surgery in treating pancreatic cancer.

PRIMARY OBJECTIVES:

I. To assess 2-year overall survival in each treatment arm (fluorouracil, irinotecan
hydrochloride, and oxaliplatin [modified (m)FOLFIRINOX] and gemcitabine [gemcitabine
hydrochloride]/nab-paclitaxel [paclitaxel albumin-stabilized nanoparticle formulation]) in
patients with resectable pancreatic cancer.

II. If the stated threshold is met in one or both arms: to choose the better regimen with
respect to 2-year overall survival.

SECONDARY OBJECTIVES:

I. To estimate, for all patients and within treatment arms: frequency and severity of adverse
events associated with chemotherapy in the perioperative setting.

II. To estimate, for all patients and within treatment arms: proportion of patients going to
surgery for resection after preoperative chemotherapy.

III. To estimate, for all patients and within treatment arms: proportion of patients
achieving macroscopically complete tumor removal with negative microscopic surgical margins
(R0) resection after preoperative chemotherapy.

IV. To estimate, for all patients and within treatment arms: overall response rate following
preoperative chemotherapy, including confirmed and unconfirmed, complete and partial
response, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

V. To estimate, for all patients and within treatment arms: pathologic response rates after
R0 or macroscopically complete tumor removal with any positive microscopic surgical margin
(R1) resection.

VI. To estimate, for all patients and within treatment arms: patterns of recurrence
(loco-regional, distant) after R0 or R1 resection.

VII. To estimate, for all patients and within treatment arms: disease-free survival from the
time of R0 or R1 resection.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours and irinotecan
hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive fluorouracil IV over
46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence
of disease progression or unacceptable toxicity. Patients achieving stable disease or better
undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8
weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin,
irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or
unacceptable toxicity.

ARM II: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment
repeats every 28 days for 3 courses in the absence of disease progression or unacceptable
toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after
completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy,
patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle
formulation and gemcitabine hydrochloride treatment in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 2 years.

Inclusion Criteria:

- Patients must have histologically or cytologically proven pancreatic adenocarcinoma;
histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible

- Patients must have measurable disease in the pancreas; computed tomography (CT) scans
or magnetic resonance imaging (MRIs) used to assess measurable disease must have been
completed within 28 days prior to registration; all disease must be assessed and
documented on the baseline tumor assessment form

- Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT
or MRI without contrast as part of positron emission tomography [PET]/CT or PET/MRI is
NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of
the chest, abdomen, and pelvis, where resectable is defined as:

- No involvement of the celiac artery, common hepatic artery, and superior
mesenteric artery (and, if present, replaced right hepatic artery)

- No involvement, or < 180° interface between tumor and vessel wall, of the portal
vein and/or superior mesenteric vein; and patent portal vein/splenic vein
confluence

- No evidence of metastatic disease

- Note: for tumors of the body and tail of the pancreas, involvement of the splenic
artery and vein of any degree is considered resectable disease

- CT scans or MRIs used to assess disease at baseline must be submitted for central
review

- Patients must have surgical consult to verify patient is a surgical candidate within
21 days prior to registration

- Patients must not have received prior surgery, radiation therapy, chemotherapy,
targeted therapy, or any investigational therapy for pancreatic cancer

- Patients must have a Zubrod performance status of 0-1

- Absolute neutrophil count (ANC) >= 1,500/mcL

- Platelets >= 100,000/mcL

- Hemoglobin >= 9 g/dL

- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN

- Serum albumin >= 3 g/dL

- Serum creatinine =< IULN within 14 days prior to registration

- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements will NOT be eligible

- No prior malignancy is allowed except for adequately treated basal (or squamous cell)
skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or
other cancer for which the patient has been disease and treatment-free for two years

- Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method for up to 3 months after the
final administered dose of chemotherapy; a woman is considered to be of "reproductive
potential" if she has had menses at any time in the preceding 12 consecutive months;
in addition to routine contraceptive methods, "effective contraception" also includes
heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect
of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or
bilateral tubal ligation; however, if at any point a previously celibate patient
chooses to become heterosexually active during the time period for use of
contraceptive measures, he/she is responsible for beginning contraceptive measures

- Sites must seek additional patient consent for the future use of specimens

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines

- As a part of the OPEN registration process the treating institution's identity is
provided in order to ensure that the current (within 365 days) date of institutional
review board approval for this study has been entered in the system
We found this trial at
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Principal Investigator: Tareq Al Baghdadi
Phone: 208-367-7954
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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Bremerton, Washington 98310
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Maura M. Barry
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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Seattle, Washington 98104
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98-1079 Moanalua Road
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'Aiea, Hawaii 96701
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2226 Liliha Street
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1 Akron General Ave
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1111 Duff Ave
Ames, Iowa 50010
(866) 972-5477
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McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99504
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Anchorage, Alaska 98508
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Mark M. Zalupski
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Antigo, Wisconsin 54409
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Antioch, California 94531
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
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Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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Asheville, North Carolina 28803
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1625 Maple Lane
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Atlanta, Georgia 30322
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550 Peachtree St NE
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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2000 Ogden Ave
Aurora, Illinois 60504
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Austin, Texas 78705
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Austin, Texas 78745
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3325 Pocahontas Road
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4305 New Shepherdsville Road
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
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Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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3535 Pentagon Boulevard
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Bellflower, California 90706
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Bellingham, Washington 98225
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
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Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Bend, Oregon 97701
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Berkeley, California 94704
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Billings, Montana 59101
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
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Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Birmingham, Alabama 35233
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
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Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: James L. Wade
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Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bloomington, Illinois 61701
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, Idaho 83706
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1501 North Oakland Drive
Bolivar, Missouri 65613
417-326-7200
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Central Care Cancer Center at Carrie J. Babb Cancer Center Cancer treatment often requires a...
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Bonne Terre, Missouri 63628
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Boone, Iowa 50036
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Boston, Massachusetts 02118
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
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Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
Phone: 888-203-7267
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Brainerd, MN
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Branson, Missouri 65616
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
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Branson, MO
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Bremerton, Washington 98310
Principal Investigator: Mehmet S. Copur
Phone: 866-844-9355
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Bremerton, WA
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
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Brewer, ME
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: Tareq Al Baghdadi
Phone: 208-367-7954
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Brighton, MI
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: Tareq Al Baghdadi
Phone: 208-367-7954
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Brighton, MI
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Bristol, Tennessee 37620
Principal Investigator: Asheesh Shipstone
Phone: 423-224-5593
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Bristol, TN
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Bristol, Tennessee 37620
Principal Investigator: Asheesh Shipstone
Phone: 423-578-8538
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Bristol, TN
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Bristol, Virginia 24201
Principal Investigator: Asheesh Shipstone
Phone: 423-224-5593
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Bristol, VA
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Bronx, New York 10467
Principal Investigator: Lakshmi Rajdev
Phone: 718-904-2730
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Bronx, NY
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Bronx, New York 10461
Principal Investigator: Lakshmi Rajdev
Phone: 718-904-2730
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Bronx, NY
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Bronx, New York 10461
Principal Investigator: Lakshmi Rajdev
Phone: 718-904-2730
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Bronx, NY
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Bryan, Texas 77802
Principal Investigator: Mehmet S. Copur
Phone: 979-774-0808
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Bryan, TX
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Principal Investigator: Albert S. DeNittis
Phone: 484-476-2649
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Bryn Mawr, PA
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