S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:6/3/2018
Start Date:January 2014
End Date:October 2020

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S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma

This partially randomized phase I/II trial studies the side effects and best dose of
pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination
chemotherapy and to see how well they work compared with combination chemotherapy alone in
treating patients with newly diagnosed pancreatic cancer that has spread to other places in
the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better
by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as
leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, 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. It is not yet known whether
combination chemotherapy is more effective with or without pegylated recombinant human
hyaluronidase in treating pancreatic cancer.

PRIMARY OBJECTIVES:

I. To assess the safety of modified leucovorin calcium, fluorouracil, irinotecan
hydrochloride and oxaliplatin (mFOLFIRINOX) in combination with PEGPH20 and select the
optimal dose of PEGPH20 for the phase II portion in patients with metastatic pancreatic
adenocarcinoma. (Phase I) II. To assess the overall survival of patients with metastatic
pancreatic adenocarcinoma treated with mFOLFIRINOX + PEGPH20 compared to those treated with
mFOLFIRINOX alone. (Phase II)

SECONDARY OBJECTIVES:

I. To assess progression free survival (PFS) in patients receiving mFOLFIRINOX with PEGPH20
and patients receiving mFOLFIRINOX alone in this patient population.

II. To assess objective tumor response (confirmed and unconfirmed, complete and partial) in
patients with measurable disease treated with mFOLFIRINOX with PEGPH20 and patients receiving
mFOLFIRINOX alone in this patient population.

III. To determine the frequency, severity, and tolerability of adverse events of mFOLFIRINOX
with PEGPH20.

TERTIARY OBJECTIVES:

I. To explore the correlation of maximum decrease in cancer antigen (CA) 19-9 levels and time
to maximum decrease in CA 19-9 levels with overall survival, progression-free survival and
response.

II. To explore the correlation of plasma hyaluronan (HA) and tumor expression of HA with
overall survival, progression-free survival and response.

OUTLINE: This is a phase I, dose de-escalation study of pegylated recombinant human
hyaluronidase followed by a randomized phase II study.

PHASE I: Patients receive pegylated recombinant human hyaluronidase intravenously (IV) over
10 minutes on day 1*; oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and
irinotecan hydrochloride IV over 1.5 hours on day 2; and fluorouracil IV over 46 hours on
days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity.

PHASE II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and
irinotecan hydrochloride IV over 1.5 hours on day 2, and fluorouracil IV over 46 hours on
days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity.

ARM II: Patients receive pegylated recombinant human hyaluronidase IV over 10 minutes on day
1* and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and fluorouracil as in Arm
I. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity.

*NOTE: Some patients also receive pegylated recombinant human hyaluronidase on day 3 or 4 of
courses 1 and 2.

After completion of study treatment, patients are followed up for 3 years.

- Patients must have newly diagnosed, untreated metastatic histologically or
cytologically documented pancreatic adenocarcinoma; patients must not have known
history of brain metastases

- Patients must have measurable metastatic disease; computed tomography (CT) scans or
magnetic resonance imaging (MRI)s used to assess measurable disease must have been
completed within 28 days prior to registration; CT scans or MRIs used to assess
non-measurable disease must have been completed within 42 days prior to registration;
CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form
(Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)

- Patients must not have had any prior treatment with oxaliplatin or irinotecan within 3
years prior to registration; patients must not have had prior chemotherapy in
metastatic setting; prior abdominal radiation therapy is not allowed

- 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 =< institutional upper limit of normal (IULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 X IULN
in the absence of liver metastases or =< 5.0 x IULN with liver metastasis

- Serum albumin >= 3 g/dL

- Serum creatinine =< ULN within 14 days prior to registration OR calculated creatinine
clearance > 50 ml/min; the serum creatinine value used in the calculation must have
been obtained within 14 days prior to registration

- Patients must have international normalized ratio (INR) =< 1.2 within 14 days prior to
registration; patients must not be receiving warfarin for therapeutic use, have
history of cerebrovascular accident (CVA), history of transient ischemic attack (TIA)
requiring intervention or treatment, pre-existing carotid artery disease requiring
intervention or treatment, or current use of megestrol acetate (use within 10 days of
registration)

- Patients must not be receiving chronic treatment (equivalent of prednisone > 10
mg/day) with systemic steroids or other immuno-suppressive agent

- Patients must not have liver disease such a cirrhosis, chronic active hepatitis or
chronic persistent hepatitis

- Patients must not have active bleeding or a pathological condition that is associated
with a high risk of bleeding

- Patients with a known history of human immunodeficiency virus (HIV) must not be on
active treatment for HIV

- Patients must have no non-malignant medical illnesses that are uncontrolled or whose
control may be jeopardized by the treatment with protocol therapy

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or any
other cancer from which the patient has been disease free for five years

- Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method; 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; if at any point a previously
celibate patient chooses to become heterosexually active during the time period for
use of contraceptive measures outlined in the protocol, he/she is responsible for
beginning contraceptive measures

- Patients must have tumor (paraffin block or slides) available for submission and be
willing to submit tumor and blood samples

- Patients or their legally authorized representative 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 Oncology Patient Enrollment Network (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

- Patients planning to enroll in the phase I portion of this study must first have a
slot reserved in advance of the registration; all site staff will use OPEN to create a
slot reservation
We found this trial at
154
sites
Trumbull, Connecticut 06611
Principal Investigator: Howard S. Hochster
Phone: 203-785-5702
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
Principal Investigator: Vincent Chung
Phone: 800-826-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Gary E. Goodman
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Seattle, Washington 98104
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Aberdeen, Washington 98520
Principal Investigator: Gary E. Goodman
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Anacortes, Washington 98221
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Anchorage, Alaska 98508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
Principal Investigator: James M. Granfortuna
Phone: 336-832-0821
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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Auburn, California 95602
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Bellingham, Washington 98225
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Bend, Oregon 97701
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Berkeley, California 94704
Principal Investigator: Ari D. Baron
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Bloomington, Illinois 61701
Principal Investigator: James L. Wade
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Bonne Terre, Missouri 63628
Principal Investigator: James L. Wade
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Burbank, California
Principal Investigator: Gary E. Goodman
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Burlingame, California 94010
Principal Investigator: Ari D. Baron
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Burlington, North Carolina 27216
Principal Investigator: James M. Granfortuna
Phone: 336-832-0821
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Principal Investigator: James L. Wade
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Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: James L. Wade
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Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Principal Investigator: James L. Wade
Phone: 217-876-4740
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Carbondale, Illinois 62902
Principal Investigator: James L. Wade
Phone: 217-876-4740
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Castro Valley, California 94546
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Centralia, Illinois 62801
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Centralia, Washington 98531
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Carolyn D. Britten
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Clackamas, Oregon 97015
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clinton, North Carolina 28328
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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Coos Bay, Oregon 97420
Principal Investigator: Gary E. Goodman
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Corona, California 92879
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Costa Mesa, California 92627
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Davis, California 95616
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Decatur, Illinois 62526
Principal Investigator: James L. Wade
Phone: 217-876-4740
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: James L. Wade
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Derby, Connecticut 06418
Principal Investigator: Howard S. Hochster
Phone: 203-785-5702
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Philip A. Philip
Phone: 313-576-9363
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Edmonds, Washington 98026
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
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Effingham, Illinois 62401
Principal Investigator: James L. Wade
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101 S Major St
Eureka, Illinois 61530
309-467-2371
Principal Investigator: James L. Wade
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Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Principal Investigator: Gary E. Goodman
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Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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Fairfield, Connecticut 06824
Principal Investigator: Howard S. Hochster
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Farmington Hills, Michigan 48334
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Fruitland, Idaho 83619
Principal Investigator: Gary E. Goodman
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Galesburg, Illinois 61401
Principal Investigator: James L. Wade
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3315 N Seminary St
Galesburg, Illinois 61401
309-344-9269
Principal Investigator: James L. Wade
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Illinois CancerCare - Galesburg Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Goldsboro, North Carolina 27534
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
(919) 736-1110
Principal Investigator: James N. Atkins
Phone: 919-580-0000
Wayne Memorial Hospital Wayne Memorial Hospital, an affiliate of Wayne Health Corporation, is home to...
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501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
Principal Investigator: James M. Granfortuna
Phone: 336-832-0821
Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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Hartford, Connecticut 06105
Principal Investigator: Howard S. Hochster
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Hendersonville, North Carolina 28971
Principal Investigator: James E. Radford
Phone: 828-696-4716
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Hendersonville, North Carolina 28791
Principal Investigator: James E. Radford
Phone: 828-696-4716
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Independence, Missouri 64057
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
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Issaquah, Washington 98029
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
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Jacksonville, North Carolina 28546
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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1432 Southwest Blvd.
Jefferson City, Missouri 65109
(573) 632-4800
Principal Investigator: James L. Wade
Phone: 217-876-4740
Capital Region Medical Center-Goldschmidt Cancer Center At the Goldschmidt Cancer Center in Jefferson City, board...
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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5400 N Oak Trafficway, Suite 101
Kansas City, Missouri 64118
(855) 603-3282
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
Heartland Hematology Oncology Associates, Incorporated Heartland Hematology-Oncology Associates PA in Kansas, Missouri, is a private...
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Kennewick, Washington 99336
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205 Tenney St
Kewanee, Illinois 61443
309-852-0596
Principal Investigator: James L. Wade
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Lacey, Washington 98503
Principal Investigator: Gary E. Goodman
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100 NE St Lukes Blvd
Lee's Summit, Missouri 64086
(816) 347-5000
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
Saint Luke's East - Lee's Summit Founded in 2006, Saint Luke
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Lenexa, Kansas 66219
Principal Investigator: Rakesh Gaur
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Lenexa, Kansas 66219
Principal Investigator: Rakesh Gaur
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Liberty, Missouri 64068
Principal Investigator: Rakesh Gaur
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Longview, Washington 98632
Principal Investigator: Gary E. Goodman
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Syma Iqbal
Phone: 323-865-0451
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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1983 Marengo St
Los Angeles, California 90033
(323) 226-2622
Los Angeles County-USC Medical Center The origins of LAC+USC Medical Center date back to 1878,...
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501 E Grant
Macomb, Illinois 61455
309-833-3503
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare - Macomb Illinois CancerCare is one of the largest private oncology and hematology...
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Marysville, California 95901
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Mebane, North Carolina 27302
Principal Investigator: James M. Granfortuna
Phone: 336-832-0821
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Meridian, Idaho 83642
Principal Investigator: Gary E. Goodman
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1700 Coffee Rd
Modesto, California 95355
(209) 526-4500
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
Memorial Medical Center Memorial is affiliated with Sutter Health, a family of not-for-profit hospitals, physician...
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Mountain View, California 94040
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Mountain View, California 94040
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Nampa, Idaho 83686
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Howard S. Hochster
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1001 Providence Dr
Newberg, Oregon 97132
(503) 537-1555
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
Providence Newberg Medical Center Providence Health & Services in Oregon, ranked as one of the...
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North Haven, Connecticut 06473
Principal Investigator: Howard S. Hochster
Phone: 203-785-5702
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Novato, California 94945
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Orange, California 92868
Principal Investigator: Tara E. Seery
Phone: 877-827-8839
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Orange, Connecticut 06477
Principal Investigator: Howard S. Hochster
Phone: 203-785-5702
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Oregon City, Oregon 97045
Principal Investigator: Gary E. Goodman
Phone: 509-897-3320
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Ottawa, Illinois 61350
Principal Investigator: James L. Wade
Phone: 217-876-4740
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1200 Starfire Drive
Ottawa, Illinois 61350
815-431-9270
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare-Ottawa Clinic Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases....
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5721 W 119th St
Overland Park, Kansas 66209
(913) 498-6000
Principal Investigator: Rakesh Gaur
Phone: 913-948-5588
Menorah Medical Center Menorah Medical Center (MMC), a full-service, acute care hospital located on the...
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