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A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer
This study is currently recruiting participants.
Verified by University of Michigan Cancer Center, September 2008
First Received: January 2, 2008   Last Updated: September 2, 2008   History of Changes
Sponsors and Collaborators: University of Michigan Cancer Center
Rush University Medical Center
Information provided by: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00593866
  Purpose

This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.


Condition Intervention Phase
Pancreatic Cancer
Radiation: INTENSITY MODULATED RADIOTHERAPY
Biological: Gemcitabine
Phase I
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer Radiation Therapy
Drug Information available for: Gemcitabine Gemcitabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • To determine the maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas. [ Time Frame: on tmt and up to 13 week post radiation follow-up/and 18m subsequent to this ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate the rates of local progression and time to local progression in patients treated with this regimen. [ Time Frame: patients are followed indefinitely ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: May 2006
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: INTENSITY MODULATED RADIOTHERAPY
    Five fractions weekly, fraction size determined by dose level
    Biological: Gemcitabine
    Gemcitabine 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
  Eligibility

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

Inclusion Criteria:

  • Is the patient 18 years of age or older.
  • Does the patient have histologically or cytologically proven carcinoma of the pancreas
  • Is the tumor unresectable or medically inoperable
  • Does the patient have a Zubrod performance status of ≤ 2 (appendix I).
  • Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3
  • Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present
  • Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy
  • If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment
  • Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent

Exclusion Criteria:

  • Does the patient have a neuroendocrine tumor of the pancreas
  • Does the patient have metastatic disease
  • Does the patient have a history of abdominal radiation therapy
  • Is there history of more than 1 month of therapy with single agent gemcitabine
  • Has the patient used any investigational agent in the month before enrollment into the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593866

Contacts
Contact: Monika R Benedict-Blue, BSW 734-936-4596 shabla@umich.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612-3833
Contact: Ross Abrams, MD     312-942-5771     Ross_A_Abrams@rush.edu    
Contact: William Leslie, MD            
Principal Investigator: Ross Abrams, MD            
Sub-Investigator: William Leslie, MD            
United States, Michigan
University Of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-5010
Contact: Edgar Ben-Josef, MD     734-936-8207     edgarb@umich.edu    
Contact: Mark Zalupski, MD     734-615-3969     zalupski@umich.edu    
Principal Investigator: Edgar Ben-Josef, MD            
Sub-Investigator: Mark Zalupski, MD            
Sponsors and Collaborators
University of Michigan Cancer Center
Rush University Medical Center
Investigators
Principal Investigator: Edgar Ben-Josef, MD University of Michigan
  More Information

No publications provided

Responsible Party: University of Michigan ( Edgar Ben-Josef, MD )
Study ID Numbers: UMCC 2006.018, IRB #HUM3315
Study First Received: January 2, 2008
Last Updated: September 2, 2008
ClinicalTrials.gov Identifier: NCT00593866     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
Patients who have confirmed cancer arising from the pancreas

Study placed in the following topic categories:
Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Antiviral Agents
Immunosuppressive Agents
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009