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Brief Title: S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
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
Study ID: NCT01959139
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, 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 Clinic Cancer Treatment Center-Valley, Spokane Valley, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown, Spokane, 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
Name: Ramesh K Ramanathan, M.D.
Affiliation: Virginia G. Piper Cancer Center
Role: STUDY_CHAIR