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Trial record 5 of 852 for:    Pancreatic Cancer AND Progression-free survival

Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine, Abraxane, Gemcitabine)

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ClinicalTrials.gov Identifier: NCT01845805
Recruitment Status : Recruiting
First Posted : May 3, 2013
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
To improve progression free survival in high risk patients with resected pancreatic adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of adjuvant therapy.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: oral azacitidine Other: Observation Drug: First-line chemotherapy after recurrence Phase 2

Detailed Description:

This trial is for patients with resected pancreatic adenocarcinoma who have concluded adjuvant therapy or were deemed unable to receive adjuvant therapy with an elevated CA 19-9 or node positive or margin positive disease. CA 19-9 elevation is defined as two levels > the institutional upper limit of normal (ULN) taken at least 2 weeks apart. These levels should be measured after adjuvant therapy has concluded or upon the decision that adjuvant therapy will not be offered. Patients will be randomized to one of two arms. Subjects enrolled due to node + disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA 19-9 elevations can enroll any time after adjuvant therapy has completed. Group A, the treatment arm, will be started on CC-486 (oral azacitidine). Group B, the control arm, will receive no additional therapy. Both Arms will evaluate CA 19-9 and have CT scans every 3 months. When patients have visible disease recurrence on imaging, CC-486 will be stopped and both groups will start first-line chemotherapy (possibly abraxane or gemcitabine).

GOALS:

To improve progression free survival in high risk patients with resected pancreatic adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in CA 19-9 treated with CC-486 (oral azacitidine)as compared to observation after completion of adjuvant therapy.

To improve response rates to first-line chemotherapy (partial and complete response) after recurrence in patients treated with CC-486 after completing adjuvant therapy.

To improve overall survival in patients with resected pancreatic adenocarcinoma treated with CC-486.

To evaluate resected pancreatic cancer tissue and biopsies at time of recurrence for epigenetic and genetic alterations to determine the pharmacodynamic effects of CC-486.

To evaluate resected pancreatic cancer tissue to identify predictive signatures of possible recurrence and the benefit of hypomethylating therapy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Improve Outcomes in Patients With Resected Pancreatic Adenocarcinoma at High Risk for Recurrence Using Epigenetic Therapy
Study Start Date : October 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: CC-486
CC-486 (oral azacitidine), 300 mg total (three 100mg tablets), taken daily on days 1-21 (of a 28 day cycle); indefinite cycles until visible tumor recurrence, then "first line chemotherapy"
Drug: oral azacitidine
Other Name: CC-486

Drug: First-line chemotherapy after recurrence
After disease recurrence, subjects on both Arm A and Arm B will start on a first-line chemotherapy (such as abraxane or gemcitabine).
Other Name: May be abraxane or gemcitabine, depending on investigator decision.

Active Comparator: Arm B: observation
Observation, indefinite until visible tumor recurrence, then "first line chemotherapy"
Other: Observation
Drug: First-line chemotherapy after recurrence
After disease recurrence, subjects on both Arm A and Arm B will start on a first-line chemotherapy (such as abraxane or gemcitabine).
Other Name: May be abraxane or gemcitabine, depending on investigator decision.




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 to 2 years ]
    The primary endpoint of the trial is to demonstrate an increase in the progression free survival (PFS) in resected pancreatic cancer patients treated with CC-486 (oral azacitidine), using RECIST.


Secondary Outcome Measures :
  1. Response rate to first-line chemo, post-recurrence [ Time Frame: 1-2 years ]
    Response rate (including partial and complete response) to first-line chemotherapy when given after visible disease recurrence in patients primed with CC-486 compared to observation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age greater than or 18 years at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R0 (negative margins) or R1 (microscopically positive margins) resection.
  • Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy. Although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy ± radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria.
  • Subjects enrolled due to node + disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA 19-9 elevations can enroll any time after adjuvant therapy has completed.
  • All previous cancer therapy including radiation, chemotherapy, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
  • Subjects must either have a CA 19-9 value > the institutional ULN on two separate checks at least 2 weeks apart OR have had an R1 resection margin OR N1 nodal disease regardless of CA 19-9 level
  • Subjects must be free of visible disease on imaging (CT, PETCT or MRI) evaluating chest, abdomen, and pelvis within 28 days of enrollment on the study.
  • Life expectancy of greater than 12 weeks
  • ECOG performance status of less than or equal to 1 at study entry
  • Subjects must have normal organ and marrow function
  • Free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
  • Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC-486 or nab-paclitaxel. All men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment.
  • Women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening.
  • Subjects must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or breastfeeding women.
  • Use of any other chemotherapy, radiotherapy, or experimental drug or therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment on study or those who have not recovered from adverse events ≥ grade 1 due to agents administered more than 4 weeks earlier except for stable grade 2 neuropathy.
  • Subjects may not receive any other concomitant investigational agents.
  • Known or suspected hypersensitivity to 5-azacitidine or mannitol
  • Known positive for HIV or infectious hepatitis, type B or C. HIV patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845805


Contacts
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Contact: Susan Sartorius-Mergenthaler, RN 410-614-3644 sartosu@jhmi.edu
Contact: Tearra Miles 410-502-5328 tlawre18@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Nilofer Azad, MD         
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Susan Sartorius-Mergenthaler, RN    410-614-3644    sartosu@jhmi.edu   
Contact: Amber-Lynn Mitcheltree, BA    410-502-5327    amiche13@jhmi.edu   
Principal Investigator: Nilo Azad, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Colin Weekes, MD, PhD    617-724-4000    cdweekes@mgh.harvard.edu   
Contact: Patricia Lynch, RN    617-643-0816    Lynch.Patricia2@mgh.harvard.edu   
Principal Investigator: Colin Weekes, MD, PhD         
United States, Pennsylvania
The Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Colleen Redlinger    215-220-9693    Colleen.Redlinger@uphs.upenn.edu   
Principal Investigator: Peter J O'Dwyer, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Nilofer Azad, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01845805     History of Changes
Other Study ID Numbers: J12138
NA_00076474 ( Other Identifier: JHM IRB )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Azacitidine
Albumin-Bound Paclitaxel
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators