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Spots Global Cancer Trial Database for S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Ramesh K Ramanathan, M.D.

Affiliation: Virginia G. Piper Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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