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SWOG-S1115: Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs MFolfox in Patients with Metastatic Pancreatic Cancer After Prior Chemotherapy

Description

PRIMARY OBJECTIVES: I. To assess overall survival in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate (selumetinib) and MK-2206 (Akt inhibitor MK2206) compared to those treated with mFOLFOX. SECONDARY OBJECTIVES: I. To assess the frequency and severity of toxicity associated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those with mFOLFOX in this patient population. TERTIARY OBJECTIVES: I. To assess progression free survival (PFS) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX. II. To assess objective tumor response in the subset of patients with measurable disease (confirmed and unconfirmed complete and partial response) in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX. III. To bank tissue and blood for future translational medicine studies. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours on days 1 and 15 and fluorouracil IV over 46-48 hours on days 1-2 and 15-16 (mFOLFOX). ARM II: Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22, and selumetinib PO daily on days 1-28. In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • Inclusion Criteria:
  • Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible
  • Patients must have distant metastatic disease; patients with macroscopic residual disease post-resection as the only site of disease are not eligible; patient must not have clinically significant ascites (defined as requiring paracentesis) or have brain metastases
  • Patients must have received one line, and no more than one line, of prior gemcitabine-based chemotherapy for advanced/metastatic pancreatic cancer and must have documentation of metastatic disease progression while on this treatment; documented disease progression must occur within 42 days of the last treatment; OR
  • For patients who received one line of gemcitabine-based chemotherapy for treatment in the adjuvant setting, recurrence to a metastatic site must be documented by imaging studies within 6 months of completing chemotherapy; chemoradiation as part of adjuvant treatment is acceptable; if the patient received one line of adjuvant gemcitabine-based treatment and had disease recurrence after 6 months of completing chemotherapy, patients will only be eligible after failing one additional line of gemcitabine-based chemotherapy used to treat the metastatic disease
  • Patients must have measurable and/or non-measurable disease; x-rays, scans. or physical examinations for assessment of measurable disease must have been completed within 28 days prior to registration; x-rays, scans, or other tests for assessment of non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
  • Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered to =< grade 1 from any of the effects of prior therapies or procedures
  • Patients must not plan to receive concurrent chemotherapy, radiotherapy, agents known to prolong corrected QT (QTc) interval, or agents known to be strong inducers or inhibitors of cytochrome P450 3A4/5 (CYP3A4/5) or cytochrome P450 1A2 (CYP1A2)
  • Patient must not have received prior treatment with fluorouracil, irinotecan, leucovorin calcium, and oxaliplatin (FOLFIRINOX), FOLFOX, oxaliplatin-based chemotherapy, mitogen-activated protein kinase (MEK) inhibitors, phosphoinositide-3-kinase (PI3K) inhibitors, or protein kinase B (AKT) inhibitors
  • Zubrod performance status of 0-1
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 9.0 g/dL
  • Patients must have adequate kidney function as evidenced by at least ONE of the following:
  • Serum creatinine =< 1.5 mg/dL within 14 days prior to registration
  • Calculated creatinine clearance >= 60 mL/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
  • Total bilirubin =< 1.5 times institutional upper limit of normal(IULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 times IULN
  • Patients must have an albumin level >= 3.0 g/dL within 14 days prior to registration
  • Patients must have an International Normalized Ratio (INR) =< 1.5 times IULN within 14 days prior to registration
  • Patients must have an electrocardiogram (ECG) within 14 days prior to registration; patients must have QTcF (by Fridericia's calculation) =< 450 msec (male) or =< 470 msec (female)
  • Patients with baseline neuropathy must be =< grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
  • Patients must not have uncontrolled diarrhea or active infection requiring antibiotics and be fully recovered from any previous serious infections within 7 days prior to registration
  • Patients must be able to swallow tablets and capsules
  • Patients with diabetes must be well controlled with fasting glucose =< grade 1 according to CTCAE v 4.0 within 14 days prior to registration
  • Patients with history of congestive heart failure must have an ejection fraction >= 55% within 14 days prior to registration
  • Patients must not have any of the following: uncontrolled hypertension, acute coronary syndrome within 6 months prior to registration, poorly controlled angina, New York Heart Association class II-IV heart failure, prior or current cardiomyopathy, atrial fibrillation, or severe valvular heart disease
  • Patients must not have a current or past history of central serous retinopathy, retinal vein occlusion, retinal detachment, or have uncontrolled glaucoma (irrespective of intraocular pressure [IOP])
  • No 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 during the study plus at least 16 weeks after last dose; 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; however, 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
  • Prestudy history and physical must be obtained within 28 days prior to registration
  • Sites must seek additional patient consent for the future use of specimens
  • All patients 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 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 into the system

Sites

  • California

    • Saint Jude Medical Center, Fullerton, California, 92835
    • University of California Medical Center At Irvine-Orange Campus, Orange, California, 92868
    • Saint Joseph Hospital - Orange, Orange, California, 92868
    • Mercy UC Davis Cancer Center, Merced, California, 95340
    • Valley Medical Oncology Consultants-Fremont, Fremont, California, 94538
    • Valley Medical Oncology Consultants, Pleasanton, California, 94588
    • East Bay Radiation Oncology Center, Castro Valley, California, 94546
    • Valley Medical Oncology Consultants-Castro Valley, Castro Valley, California, 94546
    • Highland General Hospital, Oakland, California, 94602
    • Epic Care-Oakland, Oakland, California, 94612
    • East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill, Pleasant Hill, California, 94523
    • Larry G Strieff MD Medical Corporation, Oakland, California, 94609
    • Alta Bates Summit Medical Center - Summit Campus, Oakland, California, 94609
    • Bay Area Breast Surgeons Inc, Oakland, California, 94609
    • Bay Area Tumor Institute, Oakland, California, 94609
    • Tom K Lee Inc, Oakland, California, 94609
    • Doctors Medical Center- JC Robinson Regional Cancer Center, San Pablo, California, 94806
    • Saint Helena Hospital, Saint Helena, California, 94574
  • Colorado

    • Rocky Mountain Cancer Centers - Pueblo, Pueblo, Colorado, 81008
    • Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, 80907
    • Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, 80304
    • Kaiser Permanente-Lone Tree, Lone Tree, Colorado, 80124
    • Kaiser Permanente-Franklin, Denver, Colorado, 80205
    • Kaiser Permanente-Rock Creek, Lafayette, Colorado, 80026
    • Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, 80501
  • Oregon

    • Legacy Meridian Park Hospital, Tualatin, Oregon, 97062
    • Legacy Emanuel Hospital and Health Center, Portland, Oregon, 97227
  • Washington

    • Legacy Salmon Creek Hospital, Vancouver, Washington, 98686
    • Rockwood Clinic, Spokane, Washington, 99220
    • Swedish Medical Center-Ballard Campus, Seattle, Washington, 98107
    • Cascade Cancer Center, Kirkland, Washington, 98034
  • Texas

    • Texas Tech University Health Sciences Center, Lubbock, Texas, 79430
  • Montana

    • Big Sky Oncology, Great Falls, Montana, 59405
    • Kalispell Medical Oncology, Kalispell, Montana, 59901
  • Nebraska

    • Good Samaritan Hospital, Kearney, Nebraska, 68847
    • Nebraska Cancer Research Center, Lincoln, Nebraska, 68510
    • Alegent Health Lakeside Hospital, Omaha, Nebraska, 68130
    • Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, 68124
    • Alegent Health Immanuel Medical Center, Omaha, Nebraska, 68122
    • Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106
    • Creighton University Medical Center, Omaha, Nebraska, 68131
  • Kansas

    • Cancer Center of Kansas-Manhattan, Manhattan, Kansas, 66502
  • Oklahoma

    • Oklahoma Oncology Inc, Tulsa, Oklahoma, 74104
    • Warren Cancer Research Foundation, Tulsa, Oklahoma, 74136
    • Tulsa Cancer Institute, Tulsa, Oklahoma, 74146
  • North Dakota

    • Saint Alexius Medical Center, Bismarck, North Dakota, 58501
  • Missouri

    • Kansas City Veterans Affairs Medical Center, Kansas City, Missouri, 64128
    • Centerpoint Medical Center LLC, Independence, Missouri, 64057
    • CoxHealth South Hospital, Springfield, Missouri, 65807
    • Capital Region Medical Center-Goldschmidt Cancer Center, Jefferson City, Missouri, 65109
    • Phelps County Regional Medical Center, Rolla, Missouri, 65401
  • Minnesota

    • Saint Cloud Hospital, Saint Cloud, Minnesota, 56303
  • Louisiana

    • Cancer Center of Acadiana, Lafayette, Louisiana, 70503
    • Hematology/Oncology Clinic LLP, Baton Rouge, Louisiana, 70809
    • Ochsner Baptist Medical Center, New Orleans, Louisiana, 70115
    • Louisiana State University Health Science Center, New Orleans, Louisiana, 70112
  • Iowa

    • Genesis Medical Center - East Campus, Davenport, Iowa, 52803
    • Hematology Oncology Associates-Quad Cities, Bettendorf, Iowa, 52722
  • Illinois

    • Memorial Hospital of Carbondale, Carbondale, Illinois, 62902
    • Centralia Oncology Clinic, Centralia, Illinois, 62801
    • Cancer Care Center of Decatur, Decatur, Illinois, 62526
    • Crossroads Cancer Center, Effingham, Illinois, 62401
    • Advocate Sherman Hospital, Elgin, Illinois, 60123
    • Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, 60435
    • West Suburban Medical Center, River Forest, Illinois, 60305
  • Wisconsin

    • Marshfield Clinic - Ladysmith Center, Ladysmith, Wisconsin, 54848
    • Marshfield Clinic-Wausau Center, Wausau, Wisconsin, 54401
    • Diagnostic and Treatment Center, Weston, Wisconsin, 54476
    • Saint Clare's Hospital, Weston, Wisconsin, 54476
    • Saint Mary's Hospital, Rhinelander, Wisconsin, 54501
    • D N Greenwald Center, Mukwonago, Wisconsin, 53149
  • Indiana

    • Michiana Hematology Oncology-PC Westville, Westville, Indiana, 46391
    • Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, 46360
    • IU Health La Porte Hospital, La Porte, Indiana, 46350
    • Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana, 46563
    • Northern Indiana Cancer Research Consortium, South Bend, Indiana, 46628
    • Community Howard Regional Health, Kokomo, Indiana, 46904
    • Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, 46601
    • IU Health Central Indiana Cancer Centers-East, Indianapolis, Indiana, 46219
    • South Bend Clinic, South Bend, Indiana, 46617
    • Cancer Care Partners LLC, Mishawaka, Indiana, 46545
    • Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, 46514
    • Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, 46845
  • Michigan

    • Lakeland Hospital, St. Joseph, Michigan, 49085
    • Marie Yeager Cancer Center, Saint Joseph, Michigan, 49085
  • Tennessee

    • Erlanger Medical Center, Chattanooga, Tennessee, 37403
  • Ohio

    • Oncology Hematology Care Inc-Mercy West, Cincinnati, Ohio, 45211
    • Oncology Hematology Care Inc-Healthplex, Fairfield, Ohio, 45014
    • Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, 45220
    • Oncology and Hematology Care Inc-Taft, Cincinnati, Ohio, 45219
    • Oncology Hematology Care Inc - Kenwood, Cincinnati, Ohio, 45236
    • Oncology Hematology Care Inc - Anderson, Cincinnati, Ohio, 45230
    • Bethesda North Hospital, Cincinnati, Ohio, 45242
    • Oncology Hematology Care Inc-Blue Ash, Cincinnati, Ohio, 45242
    • Fulton County Health Center, Wauseon, Ohio, 43567
  • Kentucky

    • Oncology Hematology Care Inc-Crestview, Crestview Hills, Kentucky, 41017
  • Georgia

    • Dekalb Medical Center, Decatur, Georgia, 30033
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