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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00025168
Collaborator
National Cancer Institute (NCI) (NIH)
20
Enrollment
7
Locations
21.9
Actual Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: gemcitabine hydrochloride
  • Drug: irinotecan hydrochloride
  • Radiation: radiation therapy
 Phase 2

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 Design

Study Type:
Interventional
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 :
Nov 1, 2001
Actual Primary Completion Date :
Aug 29, 2003
Actual Study Completion Date :
Aug 29, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    2 Southeastern Medical Oncology Center Goldsboro North Carolina United States 27534
    3 East Carolina University School of Medicine Greenville North Carolina United States 27858-4354
    4 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    5 Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina United States 29425
    6 Greenville Hospital System Greenville South Carolina United States 29605
    7 Spartanburg Regional Healthcare System Spartanburg South Carolina United States 29303

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT00025168
    Other Study ID Numbers:
    • REBACDR0000068933
    • CCCWFU-57100
    • NCI-5332
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    Keywords provided by Wake Forest University Health Sciences
    stage III pancreatic cancer
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Gemcitabine
    Irinotecan

    Study Results

    No Results Posted as of Sep 9, 2021