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

Study Overview

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

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.

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.

Adenocarcinoma Pancreas

OTHER: Gemcitabine
DRUG: CP-870,893

UPCC 14211

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-10-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-08-24
First Submitted that Met QC Criteria 2011-10-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-08-27
First Posted (ACTUAL) 2011-10-21	Results First Posted N/A	Last Verified 2018-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Number of participants with adverse events

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Robert Vonderheide, MD, DPhil, Abramson Cancer Center at Penn Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Rose S. Immunotherapy network launches first trial. Cancer Discov. 2012 Sep;2(9):760. doi: 10.1158/2159-8290.CD-ND2012-032. Epub 2012 Jul 26. No abstract available.

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