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Pancreatic CancerPhase 2NCT00026130

Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer

A Phase 2 study testing fluorouracil, gemcitabine hydrochloride and radiation therapy in people with Pancreatic Cancer, run by Alliance for Clinical Trials in Oncology at 77 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
fluorouracil, gemcitabine hydrochloride and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
77 sitesUnited States
Study dates
Sep 2001to Jun 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed pancreatic adenocarcinoma
  • Non-metastatic disease that is unresectable due to any of the following:
  • Tumor greater than 5 cm
  • Bulky lymph nodes greater than 2 cm, but within the radiation port
  • Vascular involvement or impingement of major vessels
  • Involvement of colon, adrenal glands, or kidney
  • Measurable or evaluable disease
  • No prior therapy for pancreatic adenocarcinoma
  • No peritoneal seeding or other evidence of metastatic disease by laparotomy or laparoscopy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • AST no greater than 3 times upper limit of normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No myocardial infarction within the past 6 months

Other:

  • No other uncontrolled serious medical or psychiatric illness that would preclude study compliance
  • No other malignancy within the past 5 years except limited or curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • No prior abdominal radiotherapy

Surgery:

  • At least 2 weeks since prior major surgery

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36207

  • Veterans Affairs Medical Center - Asheville

    Asheville, North Carolina, 28805

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22902

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital at Ohio State University

    Columbus, Ohio, 43210-1240

  • NorthEast Oncology Associates - Concord

    Concord, North Carolina, 28025

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas, 75219

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    East Syracuse, New York, 13057

  • Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28302-2000

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Fort Wayne Medical Oncology and Hematology, Incorporated

    Fort Wayne, Indiana, 46885-5099

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • Memorial Regional Cancer Center at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Lenoir Memorial Hospital Cancer Center

    Kinston, North Carolina, 28503-1678

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Veterans Affairs Medical Center - Las Vegas

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Baptist Hospital East - Louisville

    Louisville, Kentucky, 40207

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615-7828

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island, 02906

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • West Suburban Center for Cancer Care

    River Forest, Illinois, 60305

  • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke

    Roanoke, Virginia, 24014

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • University Hospital at State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Veterans Affairs Medical Center - Washington, DC

    Washington D.C., District of Columbia, 20422

  • Zimmer Cancer Center at New Hanover Regional Medical Center

    Wilmington, North Carolina, 28402-9025

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy 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 pancreatic cancer.

Read the detailed description

OBJECTIVES:

  • Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy.
  • Determine the time to progression in patients treated with this regimen.
  • Determine the overall clinical response in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks.

Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 24 months.

Being tested
fluorouracil, gemcitabine hydrochloride, radiation therapy
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluorouracilDrug

    Also called 5FU

    200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)

  • gemcitabine hydrochlorideDrug

    200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycle

  • radiation therapyRadiation

    4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)

Study groups in NCT00026130
Study groupRoleWhat they receive
Gemcitabine + 5FU + XRTExperimentalChemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
Receives: Drug: fluorouracil; Drug: gemcitabine hydrochloride; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 9 months up to 3 years post treatment

Secondary outcomes (4)

  1. Time to progression

    Measured: After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs

  2. Clinical Response

    Measured: q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs

  3. CA19-9 Levels

    Biomarker response

    Measured: q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs

  4. Toxicity

    Measured: q cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2001
  3. Primary completionDec 2005
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00026130
Sponsor's protocol ID
CALGB-80003
Other IDs
U10CA031946, CALGB-80003, CDR0000068988
Status last verified
Jul 2016
First submitted
9 Nov 2001
Last updated
19 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Mamon HJ, Niedzwiecki D, Hollis DR, et al.: Preliminary analysis of Cancer and Leukemia Group B (CALGB) 80003: a phase II trial of gemcitabine, 5-fluorouracil (5FU), and radiation therapy (RT) in locally advanced non-metastatic pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-22, S13, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluorouracil, gemcitabine hydrochloride and radiation therapy in people with Pancreatic Cancer, run by Alliance for Clinical Trials in Oncology at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 9 months up to 3 years post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00026130, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.

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