S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
NCT ID: NCT01959139
Last Updated: 2024-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
126 participants
INTERVENTIONAL
2014-01-23
2023-11-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase II: mFOLFIRINOX
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 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin
85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin
400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan
180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil
2,400 mg/m\^2, Days 2-4, IV over 46 hours
Phase II: mFOLFIRINOX + PEGPH20
Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PEGPH20
3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin
85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin
400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan
180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil
2,400 mg/m\^2, Days 2-4, IV over 46 hours
Phase I
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes; Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours; Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours; Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours; 5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
PEGPH20
3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin
85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin
400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan
180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil
2,400 mg/m\^2, Days 2-4, IV over 46 hours
Interventions
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PEGPH20
3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin
85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin
400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan
180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil
2,400 mg/m\^2, Days 2-4, IV over 46 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Halozyme Therapeutics
INDUSTRY
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Ramesh K Ramanathan, M.D.
Role: STUDY_CHAIR
Virginia G. Piper Cancer Center
Locations
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Mills - Peninsula Hospitals
Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
City of Hope Corona
Corona, California, United States
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, United States
Sutter Davis Hospital
Davis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter General Hospital
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
City of Hope West Covina
West Covina, California, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Medical Oncology and Hematology Group PC-Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, United States
Charlotte Hungerford Hospital Center for Cancer Care
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Cancer Care Center of Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States
Kansas Institute of Medicine Cancer and Blood Center
Lenexa, Kansas, United States
Minimally Invasive Surgery Hospital
Lenexa, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Centerpoint Medical Center LLC
Independence, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States
Randolph Hospital
Asheboro, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Hendersonville Hematology and Oncology at Pardee
Hendersonville, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Cone Heath Cancer Center at Mebane
Mebane, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Saint Charles Health System
Bend, Oregon, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, United States
Bay Area Hospital
Coos Bay, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Medical Center-Edmonds
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, United States
Countries
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References
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Ramanathan RK, McDonough SL, Philip PA, Hingorani SR, Lacy J, Kortmansky JS, Thumar J, Chiorean EG, Shields AF, Behl D, Mehan PT, Gaur R, Seery T, Guthrie KA, Hochster HS. Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313. J Clin Oncol. 2019 May 1;37(13):1062-1069. doi: 10.1200/JCO.18.01295. Epub 2019 Feb 28.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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NCI-2013-01776
Identifier Type: OTHER
Identifier Source: secondary_id
S1313
Identifier Type: OTHER
Identifier Source: secondary_id
S1313
Identifier Type: -
Identifier Source: org_study_id
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