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

NCT01456585 | Completed Phase 1 DMC

• 1 other identifier: UPCC 14211
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma Pancreas

Keywords

Histological documentation; primary adenocarcinoma of the pancreas; surgically eligible; tumor resection; curative intent

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

Secondary Outcomes (1)

• Overall survival

Interventions

Gemcitabine OTHER

CP-870,893 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19004, United States

Location

Related Publications (1)

• 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.

  PMID: 22969103 DERIVED

MeSH Terms

Interventions

Gemcitabine; selicrelumab

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Robert Vonderheide, MD, DPhil

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 21, 2011
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

US (1)