Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Rush University Medical Center
Information provided by (Responsible Party):
Mark Zalupski, M.D., University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00593866
First received: January 2, 2008
Last updated: August 12, 2014
Last verified: August 2014
  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
Drug: Gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The Maximum Tolerated Radiation Dose [ Time Frame: 13 weeks post radiation ] [ Designated as safety issue: Yes ]
    The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.


Secondary Outcome Measures:
  • The Percentage of Participants Free From Local Progression at 2 Years [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: June 2015
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation Dose Escalation with Gemcitabine

INTENSITY MODULATED RADIOTHERAPY

Radiation dose escalation:

Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4

  • BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level

Gemcitabine:

1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

Radiation: INTENSITY MODULATED RADIOTHERAPY
Five fractions weekly, fraction size determined by dose level
Other Names:
  • Radiation dose escalation:
  • Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction)
  • Level 1 45.0 1.8 53.1 45.0
  • Level 2 50.0 2.0 60.0 50.4
  • Level 3 52.5 2.1 63.5 54.0
  • Level 4 55.0 2.2 67.1 57.0
  • Level 5 57.5 2.3 70.7 60.0
  • Level 6 60.0 2.4 74.4 63.0
  • Level 7 62.5 2.5 78.1 66.2
  • Level 8 65.0 2.6 81.9 69.4
  • * BED=Biological Effective Dose; =10
Drug: 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
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: NCT00593866

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612-3833
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48109-5010
Sponsors and Collaborators
University of Michigan Cancer Center
Rush University Medical Center
Investigators
Principal Investigator: Mark Zalupski, MD University of Michigan
  More Information

No publications provided

Responsible Party: Mark Zalupski, M.D., Principal Investigator, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00593866     History of Changes
Other Study ID Numbers: UMCC 2006.018, IRB #HUM3315
Study First Received: January 2, 2008
Results First Received: August 12, 2014
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

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

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
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

ClinicalTrials.gov processed this record on August 26, 2014