A Trial of Chemo & Radiation Therapy for Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Venu Bathini, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00424827
First received: January 18, 2007
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

To assess progression-free survival of patients with locally advanced pancreatic cancer who are treated with concurrent gemcitabine, 5-FU, cetuximab and external beam radiation therapy.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine/Fluorouracil with External Beam 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 Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • To assess progression-free survival of patients with locally advanced pancreatic cancer who are treated with concurrent gemcitabine, 5-FU, cetuximab and external beam radiation therapy. [ Time Frame: 1-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To estimate the overall clinical response to chemoradiation therapy in this patient population. [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • To estimate resection rate in this population. [ Time Frame: 1-Year ] [ Designated as safety issue: No ]
  • To estimate the biomarker response to chemoradiation through evaluation of circulating CA19-9 levels. [ Time Frame: 1-Year ] [ Designated as safety issue: No ]
  • To assess the toxicity associated with this regimen. [ Time Frame: 1-Year ] [ Designated as safety issue: No ]
  • To estimate EGFR expression in tumors derived from this patient population. [ Time Frame: 1-Year ] [ Designated as safety issue: No ]
  • To detect EGFR and ras mutation in tumors derived from this patient population. [ Time Frame: 1-Year ] [ Designated as safety issue: No ]
  • To correlate specific ras and EGFR mutations with primary and secondary clinical end points [ Time Frame: 1-Year ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Drug: Gemcitabine/Fluorouracil with External Beam Radiation
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.
Other Name: EGFR Expression; Cetuximab & Radiosensitization of Cetuximab

Detailed Description:

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.

All patients will be assessed by history and physical examination including weight, vital signs, and performance status within 14 days of initiation of therapy. Baseline hematologic and biochemical profiles, including CBC with differential, alkaline phosphatase, bilirubin, SGOT (AST), BUN, creatinine, and CA 19-9 will be completed within 14 days of initiation of therapy.

During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day) delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab, gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. All patients will have a central venous access device placed to facilitate chemotherapy administration.

During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000 mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for 3 weeks followed by one-week rest for four cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Patients may not have had prior therapy for carcinoma of the pancreas, nor prior abdominal radiation therapy.
  • Age > 18 years.
  • CTC performance status < 2.
  • No myocardial infarction in the past six months.
  • No major surgery in the past two weeks.
  • No uncontrolled serious medical or psychiatric illness.
  • Required Initial Laboratory Data:

    • Total bilirubin < 2.0 mg/dl
    • AST < 3x upper limits of normal.
    • Serum creatinine < 2.0 mg/dl
    • WBC > 3,000/mm3 (ANC>1500/mm3)
    • Platelets > 100,000 mm3
    • CA 19-9
  • Required Diagnostic procedures:

    • Chest X-ray
    • Abdominal pelvic CT scan
    • EUS
    • Staging laparoscopy or staging laparotomy

Exclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424827

Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Venu Bathini, MD University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Venu Bathini, Study Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00424827     History of Changes
Other Study ID Numbers: UM200602
Study First Received: January 18, 2007
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
pancreatic cancer, gemcitabine, 5-FU, cetuximab, radiation

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

ClinicalTrials.gov processed this record on August 28, 2014