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Trial record 66 of 267 for:    Pancreatic Cancer AND Resectable

Pre-Operative Trial (PGHA vs. PGH) for Resectable Pancreatic Cancer (17-134)

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ClinicalTrials.gov Identifier: NCT03344172
Recruitment Status : Suspended (Suspected Grade 5 SAE(s) related to treatment)
First Posted : November 17, 2017
Last Update Posted : May 27, 2019
Sponsor:
Collaborators:
Pfizer
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nathan Bahary, MD, University of Pittsburgh

Brief Summary:
This is a randomized phase II trial that will examine the ability of Avelumab to improve the clinical activity of a pre-operative regimen of gemcitabine, nab-paclitaxel and hydroxychloroquine in subjects with potentially resectable adenocarcinoma of the pancreas.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Resectable Drug: Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab Drug: Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Pre-Operative Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine With or Without Avelumab (PGHA vs. PGH)
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021


Arm Intervention/treatment
Experimental: PGHA
Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab
Drug: Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab
2 cycles of gemcitabine and nab-paclitaxel (1000mg/m2 & 125mg/m2 - day 1, 8, 15) and hydroxychloroquine (1200mg/day) with Avelumab (days 1 and 15 of each 28-day cycle)
Other Name: PGHA

Experimental: PGH
Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine
Drug: Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine
2 cycles of gemcitabine and nab-paclitaxel (1000mg/m2 & 125mg/m2 - day 1, 8, 15) and hydroxychloroquine (1200mg/day)
Other Name: PGH




Primary Outcome Measures :
  1. Rate of grade IIb or higher histolopathologic response [ Time Frame: up to 3 years ]
    Number of grade IIb+lll+lllm+IV+lVm responses / total number of all grade histolopathologic responses. Histoligic appearance will be assess per the Grading System for Pathological Response: Grade I - Characteristic cytologic changes of malignancy present, but little (< 10%) or no tumor cell destruction is evident; Grade II - Characteristic cytologic changes of malignancy; 10% to 90% of tumor cells are destroyed; Grade IIa - Destruction of 10% to 50% of tumor cells; Grade IIb - Destruction of 51% to 90% of tumor cells; Grade III - Few (< 10%) viable-appearing tumor cells are present; Grade IIIm - Sizable pools of mucin present; Grade IV - No viable tumor cells present; Grade IVm - Acellular pools of mucin present.


Secondary Outcome Measures :
  1. CA19-9 response to preoperative chemotherapy compared with the control Gemcitabine/ Abraxane and hydroxychloroquine [ Time Frame: up to 3 years ]
    Preoperative and postoperative levels (values) of CA19-9 in tissues will be determined. The change in CA19-9 levels (values) will be compared between treatment arms.

  2. Autophagy biomarker levels by (histo)pathological response [ Time Frame: up to 3 years ]
    Autophagy biomarker levels in blood by (histo)pathological response (per the Grading System for Pathological Response), by treatment arm

  3. Change in Coagulation Index (CI) (or overall assessment of coagulability) [ Time Frame: up to 3 years ]
    Comparison of the preoperative and postoperative Thromboelastogram (TEG) Coagulation Index (CI), between treatment arms.

  4. Inflammatory biomarkers levels by (histo)pathological response [ Time Frame: up to 3 years ]
    Inflammatory biomarkers levels in blood by (histo)pathological response (per the Grading System for Pathological Response), by treatment arm

  5. Change in CA19-9 levels by final (histo)pathological response [ Time Frame: up to 3 years ]
    Change in CA19-9 levels in blood by (histo)pathological response (per the Grading System for Pathological Response), by treatment arm



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Has biopsy-proven adenocarcinoma of the pancreas that is determined to be potentially or borderline resectable by National Comprehensive Cancer Network (NCCN) criteria.
  • Karnofsky performance status of 70-100%.
  • No active second malignancy with the exception of basal or squamous cell carcinoma of the skin.
  • Has adequate biological parameters as demonstrated by blood counts at screening (obtained ≤14 days prior to randomization).
  • Has adequate blood chemistry levels at Baseline visit. -Age >18 years.
  • Must be able to swallow enteral medications with no requirement for a feeding tube.

Exclusion Criteria:

  • Deemed surgically unresectable or unwilling to undergo surgical resection.
  • Prior use of chemotherapy, radiotherapy, and / or investigational agents for pancreatic cancer.
  • Any evidence of metastasis to distant organs (liver, lung, peritoneum).
  • Symptomatic evidence of gastric outlet obstruction.
  • Inability to adhere to study and/or follow-up procedures.
  • History of allergic reactions or hypersensitivity to the study drugs.
  • Known or suspected HIV infection Active or history of autoimmune disease or immune deficiency.
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan.
  • Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis.
  • Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening.
  • Known clinically significant liver disease Active tuberculosis Severe infection within 4 weeks prior to initiation of study treatment Significant cardiovascular disease Grade >/= 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment.
  • Prior allogeneic stem cell or organ transplantation including corneal transplant
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies Known allergy or hypersensitivity to any of the study drugs or any of their excipients.
  • Treatment with systemic immunosuppressive medication Patients requiring the use of enzyme-inducing anti-epileptic medication Patients with previously documented macular degeneration or diabetic retinopathy are excluded.
  • Subjects with ventricular pacemaker Patients on Coumadin must be willing to switch to an alternative subcutaneous Low-molecular-weight heparin (LMWH) or oral agent.
  • Must not have intractable nausea or vomiting which prohibits the patient from oral medications Ability to understand and the willingness to sign a written informed consent document.

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): NCT03344172


Locations
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United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Nathan Bahary, MD
Pfizer
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nathan Bahary, MD UPMC Hillman Cancer Center

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Responsible Party: Nathan Bahary, MD, associate professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03344172     History of Changes
Other Study ID Numbers: HCC# 17-134
R01CA181450 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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
Hydroxychloroquine
Paclitaxel
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents