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A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC)


Inclusion Criteria:



- Histologically or cytologically confirmed unresectable non-metastatic adenocarcinoma
of the pancreas

- AJCC stage I-III with unresectable or borderline unresectable disease as defined by
NCCN guidelines

- Radiological resectability is defined by the following criteria on abdominal imaging:

1. No evidence of tumor extension to the celiac axis, hepatic artery or superior
mesenteric artery.

2. No evidence of tumor encasement or occlusion of the superior mesenteric vein
(SMV) or the SMV/portal vein confluence

3. No evidence of visceral or peritoneal metastases

- Borderline and Unresectable cases would be defined as those that do not meet the
criteria in section and also show no evidence of distant metastatic or
intraperitoneal disease.

- Eastern Cooperative Oncology Group performance status of ≤ 2

- Age > 18 years

- Adequate hematologic reserve, hepatic reserve and renal function

- WBC > 2,000 cells/mm3

- ANC > 1,500 cells/mm3

- Platelets > 100,000 cells/mm3

- Serum bilirubin ≤ 2.5 mg/dL

- Serum creatinine ≤ 2 x upper limit of normal (ULN), or creatinine clearance (Ccr) ≥
30ml/min

- ALT < 3 times ULN

- AST < 3 times ULN

- Albumin > 3.2 g/dl

- Patient must sign study-specific informed consent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the one-year survival rate

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Gary Yang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University

Authority:

United States: Institutional Review Board

Study ID:

5110324

NCT ID:

NCT01683422

Start Date:

December 2011

Completion Date:

December 2017

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Loma Linda University Medical CenterLoma Linda, California  92354