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Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma

Phase 2
18 Years
Not Enrolling
Pancreatic Adenocarcinoma

Thank you

Trial Information

Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma

Although surgery is the only curative modality for pancreatic adenocarcinoma, the majority
of patients (~80%)are unresectable at presentation. The use of a multimodality approach may
be a crucial method to improve the dismal survival rate of patients with pancreatic cancer.
A logical tactic is to use neoadjuvant cytotoxic agents and targeted drugs to facilitate

Inclusion Criteria:

- Patients must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma.
Patients with endocrine tumors or lymphoma of the pancreas are ineligible.

- Patients must have locally advanced disease that is considered to be "borderline"
surgically resectable (see Section 4.0). Patients with metastatic disease or grossly
resectable disease on presentation are ineligible.

- Patients must have measurable disease prior to starting this study. Patients with
primarily non-measurable disease, including lesions to small to be characterized,
effusions, ascites, diffuse bone disease, diffuse skin disease, leptomeningeal
disease, lymphangitis, pneumonitis or disease measured by indirect or biochemical
means, are not eligible. Testing for measurable disease must have been completed 28
days prior to registration.

- Patients must consent to utilization of tissue for research in this protocol. Tissue
will be evaluated via immunohistochemical staining for deoxycytidine kinase, ERCC-1
and ERCC-2 (XPD). Patients may be asked if they are willing to allow their tissue to
be used for future studies that are not defined in this protocol. Disallowing the
use of tissue for future studies does not limit eligibility in this protocol.

- Patients must fulfill the required initial laboratory data to be obtained within 28
days prior to registration: AGC ≥ 1,500cells/μL, Platelet ≥ 100,000cells/μL, Hgb >
8.0 g/dl, Bilirubin ≤ 2.0 X IULN, Serum Creatinine ≤ 2.0mg/dL, AST(SGOT) ≤ 2.5x
IULN, ALT(SGPT) ≤ 2.5x IULN, CA19-9 (any value),

- Patients must have an ECOG/Zubrod performance status of 0-2.

- Patients must be able to read and understand English in order to participate in this
study, or have a certified translator present.

- Due to the potentially harmful effects of chemotherapy on a developing fetus,
patients who are pregnant are planning to become pregnant, or who are lactating
should not participate in this study.

- Women of childbearing potential must have a negative pregnancy test.

- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.

- All patients must be informed of the investigational nature of this study and must
sign, date and give written consent in accordance with institutional and federal

- All patients must be18 years of age or older to participate.

Exclusion Criteria:

- Patients with known brain metastases are ineligible. Brain imaging studies are not
required for eligible patients with no neurologic signs or symptoms. If brain
imaging studies are performed, they must be negative for disease.

- Patients who have had prior surgery for their pancreatic carcinoma are not eligible
for this study. This does not include patients who have had cytologic brushing, fine
needle aspiration or core biopsy of their tumor for diagnostic purposes.

- Patients must not have received prior chemotherapy, radiotherapy, chemoradiotherapy,
surgery, immunotherapy or hormonal therapy for pancreatic cancer.

- Patients must not have received prior erlotinib or other therapies that target EGFR.
Patients must not have received prior tyrosine kinase inhibitors.

- Have a significant history of uncontrolled cardiac disease including uncontrolled
hypertension, unstable angina or uncontrolled congestive heart failure.

- Have a significant history of intersitital lung disease

- Have a significant history of peripheral neuropathy (grade must be <1) or
mononeuropathy multiplex.

- Have temperature >101.30 F or active infection

- No other history of malignancy is allowed except for the following:

adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.

- There must be no other plans for the patient to receive concurrent chemotherapy,
radiotherapy, chemoradiotherapy, surgery, immunotherapy or hormonal therapy for the
treatment of their cancer while on protocol.

- Due to the undetermined effect of chemotherapy in patients with HIV infection and the
potential for serious interaction with anti-HIV medications, patients who are known
to be infected with HIV are not eligible for this study. An HIV test is not required
to participate.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is a dichotomous variable evaluating the # of patients who obtain an RO resection versus the number of patients that do not obtain an RO resection plus the number of patients who are not resectable.

Outcome Time Frame:

9-10 months

Safety Issue:


Principal Investigator

Leslie Oleksowicz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati


United States: Institutional Review Board

Study ID:




Start Date:

August 2008

Completion Date:

August 2010

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



University of Cincinnati Cincinnati, Ohio  45267-0502