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

NCT01959139 | Completed Phase 1 Results DMC

• 3 other identifiers: S1313NCI-2013-01776U10CA180888
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 154

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Progression Free Survival (PFS) (Phase II)

  From date of registration to date of death due to any cause, assessed up to 3 years

• Objective Tumor Response Rate (Confirmed and Unconfirmed, Complete and Partial)

  Up to 3 years

• Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

  Duration of treatment and follow up until death or 3 years post registration

Other Outcomes (3)

• Cancer Antigen (CA) 19-9 Levels

  Within 2 years of the end of the study

• Plasma Expression of Hyaluronan (HA)

  Within 2 years of end of study

• Tumor Expression of HA

  Within 2 years of end of study

Study Arms (3)

Phase II: mFOLFIRINOX

ACTIVE COMPARATOR

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.

Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-fluorouracil

Phase II: mFOLFIRINOX + PEGPH20

EXPERIMENTAL

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.

Drug: PEGPH20; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-fluorouracil

Phase I

EXPERIMENTAL

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

Drug: PEGPH20; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-fluorouracil

Interventions

PEGPH20 DRUG

3 ug/kg on Day 1, IV over 15 minutes

Also known as: Pegylated Recombinant Human Hyaluronidase

Phase I; Phase II: mFOLFIRINOX + PEGPH20

Oxaliplatin DRUG

85 mg/m\^2, on Day 2, IV over 2 hours

Also known as: Eloxatin, NSC-266046

Phase I; Phase II: mFOLFIRINOX; Phase II: mFOLFIRINOX + PEGPH20

Leucovorin DRUG

400 mg/m\^2, on Day 2, IV over 2 hours

Also known as: leucovorin calcium

Phase I; Phase II: mFOLFIRINOX; Phase II: mFOLFIRINOX + PEGPH20

Irinotecan DRUG

180 mg/m\^2, on Day 2, IV over 1.5 hours

Also known as: CPT-11, NSC-616348

Phase I; Phase II: mFOLFIRINOX; Phase II: mFOLFIRINOX + PEGPH20

5-fluorouracil DRUG

2,400 mg/m\^2, Days 2-4, IV over 46 hours

Also known as: 5-FU, Adrucil, NSC-19893

Phase I; Phase II: mFOLFIRINOX; Phase II: mFOLFIRINOX + PEGPH20

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Halozyme Therapeutics: collaborator

Study Sites (154)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508, United States

Location

Alaska Women's Cancer Care

Anchorage, Alaska, 99508, United States

Location

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

Location

The University of Arizona Medical Center-University Campus

Tucson, Arizona, 85724, United States

Location

Sutter Auburn Faith Hospital

Auburn, California, 95602, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

Mills - Peninsula Hospitals

Burlingame, California, 94010, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

Location

Eden Hospital Medical Center

Castro Valley, California, 94546, United States

Location

City of Hope Corona

Corona, California, 92879, United States

Location

UC Irvine Health Cancer Center-Newport

Costa Mesa, California, 92627, United States

Location

Sutter Davis Hospital

Davis, California, 95616, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040, United States

Location

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, 94040, United States

Location

Sutter Cancer Research Consortium

Novato, California, 94945, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter General Hospital

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

Location

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065, United States

Location

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

Location

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, 95687, United States

Location

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589, United States

Location

City of Hope West Covina

West Covina, California, 91790, United States

Location

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

Location

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

Location

Medical Oncology and Hematology Group PC-Guilford

Guilford, Connecticut, 06437, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital-Orange Care Center

Orange, Connecticut, 06477, United States

Location

Charlotte Hungerford Hospital Center for Cancer Care

Torrington, Connecticut, 06790, United States

Location

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

Location

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

Location

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Saint Luke's Mountain States Tumor Institute - Fruitland

Fruitland, Idaho, 83619, United States

Location

Saint Luke's Mountain States Tumor Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Saint Luke's Mountain States Tumor Institute - Nampa

Nampa, Idaho, 83686, United States

Location

Saint Luke's Mountain States Tumor Institute-Twin Falls

Twin Falls, Idaho, 83301, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

Cancer Care Center of Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Radiation Oncology of Northern Illinois

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, 61554, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61603, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62702, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Cancer Care Specialists of Illinois-Swansea

Swansea, Illinois, 62226, United States

Location

Kansas Institute of Medicine Cancer and Blood Center

Lenexa, Kansas, 66219, United States

Location

Minimally Invasive Surgery Hospital

Lenexa, Kansas, 66219, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Saint Luke's South Hospital

Overland Park, Kansas, 66213, United States

Location

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, 66208, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, 63628, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

Location

Centerpoint Medical Center LLC

Independence, Missouri, 64057, United States

Location

Capital Region Medical Center-Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, 64118, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States

Location

Liberty Radiation Oncology Center

Liberty, Missouri, 64068, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203, United States

Location

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, 27215, United States

Location

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328, United States

Location

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Cone Health Cancer Center

Greensboro, North Carolina, 27403, United States

Location

Hendersonville Hematology and Oncology at Pardee

Hendersonville, North Carolina, 28791, United States

Location

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546, United States

Location

Cone Heath Cancer Center at Mebane

Mebane, North Carolina, 27302, United States

Location

Annie Penn Memorial Hospital

Reidsville, North Carolina, 27320, United States

Location

Southeastern Medical Oncology Center-Wilson

Wilson, North Carolina, 27893, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Saint Charles Health System

Bend, Oregon, 97701, United States

Location

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

Location

Providence Oncology and Hematology Care Southeast

Clackamas, Oregon, 97015, United States

Location

Bay Area Hospital

Coos Bay, Oregon, 97420, United States

Location

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

Location

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 98520, United States

Location

Cancer Care Center at Island Hospital

Anacortes, Washington, 98221, United States

Location

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531, United States

Location

Swedish Medical Center-Edmonds

Edmonds, Washington, 98026, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Seattle Cancer Care Alliance at EvergreenHealth

Kirkland, Washington, 98034, United States

Location

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503, United States

Location

PeaceHealth Saint John Medical Center

Longview, Washington, 98632, United States

Location

Minor and James Medical PLLC

Seattle, Washington, 98104, United States

Location

Pacific Gynecology Specialists

Seattle, Washington, 98104, United States

Location

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Group Health Cooperative-Seattle

Seattle, Washington, 98112, United States

Location

Swedish Medical Center-First Hill

Seattle, Washington, 98122-4307, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Providence Regional Cancer System-Shelton

Shelton, Washington, 98584, United States

Location

Rockwood Cancer Treatment Center-DHEC-Downtown

Spokane, Washington, 99204, United States

Location

Rockwood Clinic Cancer Treatment Center-Valley

Spokane Valley, Washington, 99216, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362, United States

Location

Providence Regional Cancer System-Yelm

Yelm, Washington, 98597, United States

Location

Related Publications (1)

• 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.

  PMID: 30817250 DERIVED

MeSH Terms

Interventions

PEGPH20; Oxaliplatin; Leucovorin; Irinotecan; Fluorouracil

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: SWOG Statistician
• Organization: SWOG Statistical Center

mduong@fredhutch.org

2066674623

Study Officials

• Ramesh K Ramanathan, M.D.

  Virginia G. Piper Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 9, 2013
• Study Start: January 23, 2014
• Primary Completion: April 1, 2019
• Study Completion: November 9, 2023
• Last Updated: February 9, 2024
• Results First Posted: February 12, 2020

Record last verified: 2024-02

Locations

US (154)