Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
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
Verified date | February 2024 |
Source | SWOG Cancer Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | November 9, 2023 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Providence Regional Cancer System-Aberdeen | Aberdeen | Washington |
United States | Cancer Care Center at Island Hospital | Anacortes | Washington |
United States | Alaska Breast Care and Surgery LLC | Anchorage | Alaska |
United States | Alaska Women's Cancer Care | Anchorage | Alaska |
United States | Anchorage Associates in Radiation Medicine | Anchorage | Alaska |
United States | Katmai Oncology Group | Anchorage | Alaska |
United States | Providence Alaska Medical Center | Anchorage | Alaska |
United States | Randolph Hospital | Asheboro | North Carolina |
United States | Sutter Auburn Faith Hospital | Auburn | California |
United States | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California |
United States | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington |
United States | Saint Charles Health System | Bend | Oregon |
United States | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Saint Luke's Mountain States Tumor Institute | Boise | Idaho |
United States | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri |
United States | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California |
United States | Mills - Peninsula Hospitals | Burlingame | California |
United States | Cone Health Cancer Center at Alamance Regional | Burlington | North Carolina |
United States | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Memorial Hospital of Carbondale | Carbondale | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Eden Hospital Medical Center | Castro Valley | California |
United States | Centralia Oncology Clinic | Centralia | Illinois |
United States | Providence Regional Cancer System-Centralia | Centralia | Washington |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
United States | Providence Oncology and Hematology Care Southeast | Clackamas | Oregon |
United States | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina |
United States | Bay Area Hospital | Coos Bay | Oregon |
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 | Cancer Care Center of Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Smilow Cancer Hospital-Derby Care Center | Derby | Connecticut |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Swedish Medical Center-Edmonds | Edmonds | Washington |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Providence Regional Cancer Partnership | Everett | Washington |
United States | Smilow Cancer Hospital Care Center-Fairfield | Fairfield | Connecticut |
United States | Weisberg Cancer Treatment Center | Farmington Hills | Michigan |
United States | Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland | Idaho |
United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
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 | Medical Oncology and Hematology Group PC-Guilford | Guilford | Connecticut |
United States | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut |
United States | Hendersonville Hematology and Oncology at Pardee | Hendersonville | North Carolina |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Centerpoint Medical Center LLC | Independence | Missouri |
United States | Swedish Cancer Institute-Issaquah | Issaquah | Washington |
United States | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina |
United States | Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson 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 Hospital of Kansas City | Kansas City | Missouri |
United States | Kadlec Clinic Hematology and Oncology | Kennewick | Washington |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Seattle Cancer Care Alliance at EvergreenHealth | Kirkland | Washington |
United States | Providence Regional Cancer System-Lacey | Lacey | Washington |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | Kansas Institute of Medicine Cancer and Blood Center | Lenexa | Kansas |
United States | Minimally Invasive Surgery Hospital | Lenexa | Kansas |
United States | Liberty Radiation Oncology Center | Liberty | Missouri |
United States | PeaceHealth Saint John Medical Center | Longview | Washington |
United States | Los Angeles County-USC Medical Center | Los Angeles | California |
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | Fremont - Rideout Cancer Center | Marysville | California |
United States | Cone Heath Cancer Center at Mebane | Mebane | North Carolina |
United States | Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho |
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 | Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho |
United States | Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut |
United States | Yale University | New Haven | Connecticut |
United States | Providence Newberg Medical Center | Newberg | Oregon |
United States | Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut |
United States | Sutter Cancer Research Consortium | Novato | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Smilow Cancer Hospital-Orange Care Center | Orange | Connecticut |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Providence Willamette Falls Medical Center | Oregon City | Oregon |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Radiation Oncology of Northern Illinois | Ottawa | Illinois |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's South Hospital | Overland Park | Kansas |
United States | Palo Alto Medical Foundation Health Care | Palo Alto | California |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Providence Saint Vincent Medical Center | Portland | Oregon |
United States | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Annie Penn Memorial Hospital | Reidsville | North Carolina |
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 | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri |
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 | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Cooperative-Seattle | Seattle | Washington |
United States | Minor and James Medical PLLC | Seattle | Washington |
United States | Pacific Gynecology Specialists | Seattle | Washington |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | Swedish Medical Center-Ballard Campus | 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 | Central Illinois Hematology Oncology Center | Springfield | Illinois |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Springfield Clinic | Springfield | Illinois |
United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
United States | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California |
United States | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri |
United States | Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois |
United States | Charlotte Hungerford Hospital Center for Cancer Care | Torrington | Connecticut |
United States | Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California |
United States | Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut |
United States | The University of Arizona Medical Center-University Campus | Tucson | Arizona |
United States | University of Arizona Cancer Center-North Campus | Tucson | Arizona |
United States | Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho |
United States | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California |
United States | Sutter Solano Medical Center/Cancer Center | Vallejo | California |
United States | PeaceHealth Southwest Medical Center | Vancouver | Washington |
United States | Providence Saint Mary Regional Cancer Center | Walla Walla | Washington |
United States | Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut |
United States | City of Hope West Covina | West Covina | California |
United States | Southeastern Medical Oncology Center-Wilson | Wilson | North Carolina |
United States | Providence Regional Cancer System-Yelm | Yelm | Washington |
Lead Sponsor | Collaborator |
---|---|
SWOG Cancer Research Network | Halozyme Therapeutics, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cancer Antigen (CA) 19-9 Levels | Explore correlation of maximum decrease in CA 19-9 levels to maximum decrease in CA 19-9 levels with overall survival, progression-free survival and response. | Within 2 years of the end of the study | |
Other | Plasma Expression of Hyaluronan (HA) | Within 2 years of end of study | ||
Other | Tumor Expression of HA | Within 2 years of end of study | ||
Primary | Phase I: Maximum Tolerated Dose (MTD) of PEGPH20 in Combination With mFOLFIRINOX | Assess safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion. MTD of PEGPH20 in combination with mFOLFORINOX was evaluated by testing decreasing doses of PEGPH20 from 3mcg/kg on Day 1 and Day 3/4, to 3mcg/kg on Day 1 only and to 1.6 mcg/kg on Day 1 only. MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of = 17%. DLTs were defined as treatment regimen related: grade = 3 non-hematologic toxicity; grade 4 absolute neutrophil count (ANC) anemia or thrombocytopenia; grade 4 ANC lasting > 7 days; grade = 3 febrile neutropenia; grade = 3 elevation of aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin, and creatinine; delay in starting the 2nd cycle of mFOLFIRINOX by > 2 weeks due to drug related toxicity. DLT were graded using the NCI CTCAE version 4. Note: the third and lowest dose level was not reached. |
2 cycles of 14 days | |
Primary | Phase II: Overall Survival | Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed using the logrank test. |
From date of registration to date of death due to any cause, assessed up to 3 years | |
Secondary | Progression Free Survival (PFS) (Phase II) | Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact. | From date of registration to date of death due to any cause, assessed up to 3 years | |
Secondary | Objective Tumor Response Rate (Confirmed and Unconfirmed, Complete and Partial) | Objective tumor response rate (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions |
Up to 3 years | |
Secondary | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living e.g. bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event |
Duration of treatment and follow up until death or 3 years post registration |
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