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Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer

This study is currently recruiting participants.
Verified September 2012 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Gary Yang, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01683422
First received: February 17, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

The current trial will provide important data on the recurrence rates and patterns of failure using state of the art target agent, chemotherapy and proton beam technology for patients with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater would be considered evidence of a regimen potentially worthy of further study as a new treatment paradigm in one arm in a future phase III trial.


Condition Intervention Phase
Pancreatic Cancer
 Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine
Radiation: Proton Radiation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • To determine the one-year survival rate [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the frequency of serious adverse events [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: December 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiation Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine

Gemcitabine 1000 mg/m2 iv, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed.

Post-proton chemotherapy: To be started in 4 to 6 weeks after completion of proton chemotherapy. Oxaliplatin 130 mg/m2 po bid on days 2 to 15 for 14 days. The CapOx regimen (Capcitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles.

Radiation: Proton Radiation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683422

Contacts
Contact: Gary Yang, MD 909-558-4280 gyang@dominion.llumc.edu
Contact: Sandra Teichman, RN 909-558-8231 scteichm@llu.edu

Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Gary Yang, MD     909-558-4280     gyang@dominion.llumc.edu    
Principal Investigator: Gary Yang, MD            
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Gary Yang, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Gary Yang, MD, MD, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT01683422     History of Changes
Other Study ID Numbers: 5110324
Study First Received: February 17, 2012
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Erlotinib
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013