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Trial record 80 of 266 for:    Pancreatic Cancer AND Resectable

Phase 1 Study of Preoperative Gemcitabine Plus CP-870, 893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma

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ClinicalTrials.gov Identifier: NCT01456585
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This is a pilot study to evaluate the role of the addition of CP870, 893 to the neoadjuvant and adjuvant setting for patients with resectable pancreatic cancer. Patients will receive standard surgery followed by chemoradiation for their disease, but one dose of gem/cp 870,893 will be pre-op and 3 doses post-op.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Pancreas Other: Gemcitabine Drug: CP-870,893 Phase 1

Detailed Description:
This is an open-label single-arm,phase 1, trial. Ten patients with newly diagnosed resectable pancreatic carcinoma will receive gemcitabine and CP-870,893 two weeks prior to surgical resection and subsequently during standard-of-care adjuvant chemoradiation therapy (at which time CP-870,893 will be given on day 3 of each of three 28-day cycles of gemcitabine). Previously established doses of each agent will be used and each given by IV infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Phase 1 Study of Preoperative Gemcitabine Plus CP-870,893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patient With Newly Diagnosed Resectable Pancreatic Carcinoma
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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Primary Outcome Measures :
  1. Number of participants with adverse events

Secondary Outcome Measures :
  1. Overall survival


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:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological documentation of primary adenocarcinoma of the pancreas
  • Surgically eligible for tumor resection with curative intent
  • Age> 18 years old
  • ECOG PS 0 or 1
  • Adequate bone marrow function (WBC>3,000; Hgb>9; Plt>100)
  • Adequate renal function (Cr<1.5ULN)
  • Adequate hepatic function (total bilirubin WNL unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin <2x ULN; and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN
  • Signed, written informed consent

Exclusion Criteria:

  • Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms. In addition adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded.
  • Patients with M1 disease.
  • Patients with any type of recurrent pancreatic adenocarcinoma
  • Prior therapy such as chemotherapy or radiation therapy for pancreatic cancer
  • Patients with a previous history of active malignancy within 5 years prior to study entry, except 1) in situ cervical carcinoma or 2) non-melanoma skin cancer
  • Previous treatment with any other compound that targets CD40
  • Concurrent treatment with any anticancer agent outside of this protocol.
  • Prior allogeneic bone marrow transplant
  • History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjorgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis. Vitiligo is allowed.
  • History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure.
  • History of deep venous thrombosis or migratory thrombophlebitis (Trousseau);
  • Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrands's disease, or cancer-associated DIC)
  • Prior allergic reactions attributed to other monoclonal antibodies.
  • Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline.
  • Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial.
  • Concurrent or planned concurrent treatment with anticoagulant such as Coumadin or heparin, except to maintain patency of in-dwelling catheters.
  • Ongoing or active infection;treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)
  • Pregnancy or breast-feeding-female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for 12 months following the last dose of CP-870,893. All female patients with reproductive potential may not participate unless they agree to use an effective contraceptive method.
  • Other uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study procedures.

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): NCT01456585


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19004
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Robert Vonderheide, MD, DPhil Abramson Cancer Center of the University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01456585     History of Changes
Other Study ID Numbers: UPCC 14211
First Posted: October 21, 2011    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Histological documentation
primary adenocarcinoma of the pancreas
surgically eligible
tumor resection
curative intent
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antibodies, Monoclonal
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