Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer

NCT01683422 | Terminated Results DMC FDA Device

• 1 other identifier: 5110324
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• One-year Survival Rate

  Subjects will be followed after treatment completed to determine length of survival rate. The primary study objective was 1-year overall survival (OS, failure: death due to any cause). The Kaplan-Meier method was used to estimate the one-year OS. Secondary Objectives were the frequency of serious adverse events, disease control rate and progression-free survival.

  One year after treatment completed.

Study Arms (1)

Proton Radiation

EXPERIMENTAL

Pre-Proton-chemotherapy (PCT) Patients will receive a combination of the agents (Gemcitabine plus Erlotinib) for 8 weeks prior to PCT Gemcitabine 1000 mg/m2 IV, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 PCT to be started in 4 to 8 weeks after completion of Pre-PCT Proton therapy: 50.4 Gy/28 fractions (1.8 Gy per fraction) once a day for 5 ½ weeks. Chemotherapy: Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed Post-PCT to be started in 4 to 6 weeks after completion of PCT Oxaliplatin 130 mg/m2, day 1 Capecitabine 1000 mg/m2 po bid on days 2 to 15 for 14 days The CapOx regimen (Capecitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles

Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine; Radiation: Proton Radiation

Interventions

Proton, Gemcitabine, Erlotinib, Capecitabine RADIATION

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.

Proton Radiation

Proton Radiation RADIATION

Proton Radiation

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed unresectable non-metastatic adenocarcinoma of the pancreas
• The American Joint Committee on Cancer (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:
• No evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery.
• No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence
• 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
• White Blood Cell (WBC) \> 2,000 cells/mm3
• Absolute Neutrophil Count (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

You may not qualify if:

• AJCC stage IV with metastatic disease
• Eastern Cooperative Oncology Group performance status of \> 2
• Age \< 18 years
• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (1)

• Sanghvi SM, Coffman AR, Hsueh CT, Kang J, Park A, Solomon NL, Garberoglio CA, Reeves ME, Slater JD, Yang GY. A phase II trial of gemcitabine and erlotinib followed by ChemoProton therapy plus capecitabine and oxaliplatin for locally advanced pancreatic cancer. J Gastrointest Oncol. 2022 Aug;13(4):1989-1996. doi: 10.21037/jgo-22-327.

  PMID: 36092320 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Protons; Gemcitabine; Erlotinib Hydrochloride; Capecitabine; Proton Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Gary Yang
• Organization: Loma Linda University Health

gyang@llu.edu

909 558 4000

Study Officials

• Gary Yang, MD

  gyang@llu.edu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: September 11, 2012
• Study Start: January 2, 2013
• Primary Completion: February 19, 2019
• Study Completion: February 19, 2019
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)