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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

Thank you

Trial Information

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


PRIMARY OBJECTIVES:

I. To assess overall survival 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 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.

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.

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: This is a multicenter study. Patients are stratified according to duration of prior
systemic therapy line (=< 4 months vs > 4 months) and presence of liver metastasis (yes vs
no). 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.

Blood and paraffin-embedded tumor tissue samples are collected for banking and future
correlative studies.

After completion of study treatment, patients are followed up periodically for 3 years.


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; patients 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
chemotherapy for pancreatic cancer; for patients who received treatment for
advanced/metastatic disease, there must be documentation of disease progression while
on this treatment; for patients who received chemotherapy for treatment in the
adjuvant setting, recurrence to a metastatic site must be documented by imaging
studies within 6months of completing chemotherapy

- 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

- Sites must seek additional patient consent for the future use of specimens

- 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 due to unknown fetal and infant risks;
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

- Patients must have completed systemic therapy at least 28 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 from any of the effects of prior therapies
or procedures

- Patients must not plan to receive concurrent chemotherapy, radiotherapy, laxatives,
agents known to prolong QTc interval, or agents known to be potent to Cytochrome P450
CYP3A4/5 (CYP3A4/5) or Cytochrome P450 1A2 (CYP1A2)

- Patients must not have received prior treatment with leucovorin calcium,
fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX), FOLFOX, MEK
inhibitors, PI3K inhibitors, or AKT inhibitors

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

From date of registration to death due to any cause using the long-rank test, assessed up to 3 years

Safety Issue:

No

Principal Investigator

Vincent Chung

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01993

NCT ID:

NCT01658943

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

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Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
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Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
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Saint Louis-Cape Girardeau CCOPSaint Louis, Missouri  63141
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
Saint John's Mercy Medical CenterSaint Louis, Missouri  63141
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
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Wayne Memorial HospitalGoldsboro, North Carolina  27534
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Summa Barberton HospitalBarberton, Ohio  44203
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
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Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Saint Rita's Medical CenterLima, Ohio  45801
Marietta Memorial HospitalMarietta, Ohio  45750
Toledo Radiation Oncology at Northwest Ohio Onocolgy CenterMaumee, Ohio  43537
Saint Charles HospitalOregon, Ohio  43616
Toledo Community Hospital Oncology Program CCOPToledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy HospitalToledo, Ohio  43623
University of ToledoToledo, Ohio  43614
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Legacy Good Samaritan Hospital and Medical CenterPortland, Oregon  97210
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The Don and Sybil Harrington Cancer CenterAmarillo, Texas  79106
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Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Sacred Heart HospitalEau Claire, Wisconsin  54701
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
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Oconomowoc Memorial Hospital-ProHealth Care IncOconomowoc, Wisconsin  53066-3896
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
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Saint Michael's HospitalStevens Point, Wisconsin  54481
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University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Roger Maris Cancer CenterFargo, North Dakota  58122
Elkhart ClinicElkhart, Indiana  46515
Michiana Hematology Oncology PC-ElkhartElkhart, Indiana  46514
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Community Health Partners Regional Medical CenterElyria, Ohio  44035
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Evergreen Hematology and Oncology PSSpokane, Washington  99218
West Virginia University CharlestonCharleston, West Virginia  25304
Marshfield Clinic-Chippewa CenterChippewa Falls, Wisconsin  54729
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Capital Region Medical Center-Goldschmidt Cancer CenterJefferson City, Missouri  65109
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Kings County HospitalBrooklyn, New York  11203
The Mark H Zangmeister CenterColumbus, Ohio  43219
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Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center-Main CampusBurien, Washington  98166
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Legacy Salmon Creek HospitalVancouver, Washington  98686
Gundersen LutheranLa Crosse, Wisconsin  54601
Central Indiana Cancer Centers - IndianapolisIndianapolis, Indiana  46227
Kaiser Permanente-FranklinDenver, Colorado  80205
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Swedish Cancer Institute-IssaquahIssaquah, Washington  98029
Marshfield Clinic - Ladysmith CenterLadysmith, Wisconsin  54848
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California  94704
Michiana Hematology Oncology PC-MishawakaMishawaka, Indiana  46545-1470
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Sanford Clinic North-FargoFargo, North Dakota  58102
Sanford Medical Center-FargoFargo, North Dakota  58122
Summa Akron City HospitalAkron, Ohio  44304
Franciscan St. Francis HealthIndianapolis, Indiana  46237
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Saint Louis Cancer and Breast Institute-South CitySaint Louis, Missouri  63109
Toledo Clinic Cancer Centers-Bowling GreenBowling Green, Ohio  43402
Toledo Clinic Cancer Centers-MaumeeMaumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-ToledoToledo, Ohio  43623
Guthrie Clinic-Robert Packer HospitalSayre, Pennsylvania  18840
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
Sutter Pacific Medical FoundationSanta Rosa, California  95403
OnCare Hawaii-LilihaHonolulu, Hawaii  96817-3169
Ochsner Baptist Medical CenterNew Orleans, Louisiana  70115
Cancer Center of Western WisconsinNew Richmond, Wisconsin  54017
Saint Clare's HospitalWeston, Wisconsin  54476
Oncare Hawaii Inc - Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
D N Greenwald CenterMukwonago, Wisconsin  53149
Swedish Medical Center-EdmondsEdmonds, Washington  98026
Idaho Urologic Institute PAMeridian, Idaho  83642
Kaiser Permanente-ModestoModesto, California  95356