A Trial of Chemo & Radiation Therapy for Pancreatic Cancer

NCT00424827 | Completed Phase 2 Results

• 1 other identifier: UM200602
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer, gemcitabine, 5-FU, cetuximab, radiation

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  1-year

Secondary Outcomes (4)

• Biomarker Response to Chemoradiation Therapy

  1-year

• Resection Rate

  1-Year

• Overall Survival

  Up to 2 years

• Toxicity Associated With This Regimen.

  1-Year

Study Arms (1)

Gemcitabine/Fluorouracil with External Beam Radiation

EXPERIMENTAL

This protocol will assess the antitumor activity of Gemcitabine/Fluorouracil with External Beam Radiation in patients with non-metastatic, locally advanced pancreatic carcinoma.

Drug: Gemcitabine/Fluorouracil with External Beam Radiation

Interventions

Gemcitabine/Fluorouracil with External Beam Radiation DRUG

This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.

Also known as: EGFR Expression; Cetuximab & Radiosensitization of Cetuximab

Gemcitabine/Fluorouracil with External Beam Radiation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of pancreatic adenocarcinoma is required.
• Only patients with unresectable, non-metastatic tumors are eligible.
• Documentation of disease extent by endoscopic ultrasound and either laparotomy or laparoscopy must be performed within 42 days of registration.
• All patients will also be assessed by chest x-ray and abdominal-pelvic CT scan.
• Confirmation of palliative surgical bypass at the time of laparotomy or whether a biliary stent was placed will be requested.
• Disease must be locoregional and not amenable to surgery based on one or more of the following criteria:
• size of pancreatic tumor \> 5 cm.
• lymph nodes (bulky, \> 2 cm, but within a radiation port)
• vascular involvement or impingement of major vessels (superior mesenteric artery, superior mesenteric vein, portal vein, hepatic artery).
• invasion into the adjacent structures.
• Patients with either measurable or evaluable disease are eligible.
• Patients with evidence of peritoneal seeding by malignancy are not eligible for the study.
• Patients with other evidence of metastatic disease are not eligible.
• Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are ineligible.
• Patients with any other malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are ineligible.

You may not qualify if:

• Enrollment in this trial will be limited to patients for whom protocol therapy is safe and appropriate. Physicians should consider the risks and benefits of therapy together with all relevant medical and other considerations in deciding whether this protocol is appropriate for a particular patient. Specific considerations include:
• Psychiatric illness which would prevent the patient from giving informed consent.
• Serious medical illness such as uncontrolled infection, severe cardiovascular disease including recent (\< 6 months) myocardial infarction or uncontrolled congestive heart failure, or other serious illness which would limit anticipated survival to \< 12 weeks.
• Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for three months after the trial.
• Inability to swallow medication. Patients should have adequate, unassisted oral intake.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Fluorouracil; Cetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Uracil; Pyrimidinones; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bilal Piperdi, MD
• Organization: Universiy of MA Medical School

UMMScommunications@umassmed.edu

508-426-0442

Study Officials

• Venu Bathini, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 22, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05