Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025168
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the time to progression, local control, and survival of patients with locally advanced, unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy.

OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks.

Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Primary Purpose: Treatment
Official Title: Phase II Trial Of Induction Gemcitabine/CPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer
Actual Study Start Date : November 2001
Actual Primary Completion Date : August 29, 2003
Actual Study Completion Date : August 29, 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed locally advanced pancreatic cancer
  • Regional (peri-pancreatic) lymph node involvement allowed
  • Clinically or surgically staged and considered unresectable or inoperable



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 months


  • Granulocyte count at least 1,500/mm3
  • Hemoglobin at least 10 g/dL
  • Platelet count at least 100,000/mm3


  • Not specified


  • Creatinine no greater than 2.0 mg/dL


  • Not pregnant
  • Fertile patients must use effective contraception
  • No other concurrent or prior malignancy within the past 2 years except nonmelanoma skin cancer or in situ carcinoma of the cervix or breast
  • No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival to less than 2 years


Biologic therapy:

  • No concurrent anticancer immunotherapy


  • No prior chemotherapy
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • No concurrent anticancer hormonal therapy


  • No prior abdominal-pelvic radiotherapy
  • No other concurrent anticancer radiotherapy


  • See Disease Characteristics
  • At least 3 weeks since prior open abdominal surgery
  • More than 10 days since prior laparoscopy


  • No other concurrent investigational drug
  • No concurrent participation in other clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025168

United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Arthur William Blackstock, MD Wake Forest University Health Sciences

Publications of Results:
Responsible Party: Wake Forest University Health Sciences Identifier: NCT00025168     History of Changes
Other Study ID Numbers: REBACDR0000068933
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Keywords provided by Wake Forest University Health Sciences:
stage III pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors