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

September 7, 2021 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center
      • Greenville, North Carolina, United States, 27858-4354
        • East Carolina University School of Medicine
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 months

Hematopoietic:

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

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent anticancer immunotherapy

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • No concurrent anticancer hormonal therapy

Radiotherapy:

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

Surgery:

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

Other:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Arthur William Blackstock, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2001

Primary Completion (Actual)

August 29, 2003

Study Completion (Actual)

August 29, 2003

Study Registration Dates

First Submitted

October 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBACDR0000068933
  • CCCWFU-57100
  • NCI-5332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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