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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

Phase 1
18 Years
Open (Enrolling)
Adenocarcinoma Pancreas

Thank you

Trial Information

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

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

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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events

Safety Issue:


Principal Investigator

Robert Vonderheide, MD, DPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:

UPCC 14211



Start Date:

April 2012

Completion Date:

October 2013

Related Keywords:

  • Adenocarcinoma Pancreas
  • Histological documentation
  • primary adenocarcinoma of the pancreas
  • surgically eligible
  • tumor resection
  • curative intent
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Pancreatic Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283