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Pancreatic CancerPhase 3NCT00058149

Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

A Phase 3 study testing gemcitabine hydrochloride and oxaliplatin in people with Pancreatic Cancer, run by Eastern Cooperative Oncology Group at 61 sites in 2 countries.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways 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?
gemcitabine hydrochloride and oxaliplatin
How many people
Not given
Where
61 sitesin 2 countries
Study dates
Mar 2003to Jul 2006
Phase
Phase 3
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 or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma or poorly differentiated carcinoma
  • Ineligible for curative resection
  • Measurable and/or nonmeasurable disease
  • Must have evidence of disease outside prior radiation fields OR radiologically confirmed progression of disease within the radiation fields after completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,500/mm^3 OR
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 125,000/mm^3

Hepatic

  • Bilirubin < 2.0 mg/dL
  • AST < 3 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No uncontrolled cardiac disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Negative vaginal ultrasound for patients with an elevated beta human chorionic gonadotropin level
  • Fertile patients must use effective nonhormonal contraception
  • No other malignancies within the past 5 years except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy
  • No active or uncontrolled infection
  • No other active illness that would preclude study participation
  • No symptomatic sensory peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for metastatic disease
  • No prior (including adjuvant) gemcitabine or oxaliplatin
  • Prior adjuvant chemotherapy allowed provided there was more than 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer
  • Prior chemotherapy as a radiosensitizing agent allowed* NOTE: *To the primary site

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to the primary tumor site and recovered
  • No prior radiotherapy to more than 25% of the functional bone marrow

Surgery

  • See Disease Characteristics
  • Prior surgical resection allowed

Other

  • No concurrent participation in supportive care trials
  • Concurrent enrollment on protocol ECOG-E1Y03 allowed

Trial locations and contacts

61 sites in 2 countries.

61 sites in 2 countries

United States60 sites

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Medical Center of Aurora - South Campus

    Aurora, Colorado, 80012-0000

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Cancer Center at Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611-4494

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • St. Joseph Hospital

    Denver, Colorado, 80218-1191

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers - Denver Rose

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018

  • Swedish Medical Center

    Englewood, Colorado, 80112

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • La Grange Oncology Associates

    La Grange, Illinois, 60525

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-0001

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-6307

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Abramson Cancer Center at the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15236

  • St. Mary-Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Swedish-American Regional Cancer Center

    Rockford, Illinois, 61104-2315

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Rocky Mountain Cancer Centers - Thornton

    Thornton, Colorado, 80229

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

South Africa1 site

  • Pretoria Academic Hospital

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma

RATIONALE: Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

Read the detailed description

OBJECTIVES:

  • Compare survival of patients with locally advanced or metastatic pancreatic cancer treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard infusion gemcitabine.
  • Compare the toxicity of these regimens in these patients.
  • Compare the objective response in patients treated with these regimens.
  • Compare the patterns of failure and progression-free survival of patients treated with these regimens.
  • Compare the reported frequency of deep vein thrombosis and pulmonary embolism among patients treated with these regimens.
  • Compare the changes in quality of life, including improved symptom control and/or additional side effects of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2) and disease stage (locally advanced vs metastatic). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (standard treatment): Patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks followed by 1 week of rest for course 1 only. In all subsequent courses, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, with courses repeating every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then at 8 and 16 weeks.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 789 patients (263 per treatment arm) will be accrued for this study within 18 months.

Keywords
stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

Timeline

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

  1. First posted9 Apr 2003 (estimated)
  2. Study startMar 2003
  3. Primary completionJul 2006

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 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058149
Sponsor's protocol ID
CDR0000287015
Other IDs
ECOG-6201
Status last verified
Apr 2004
First submitted
7 Apr 2003
Last updated
21 Sep 2011
Results posted
No

Publications

  • Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. doi: 10.1200/JCO.2008.20.9007. Epub 2009 Jul 6.

    PubMed 19581537

  • Liebes L, Levy DE, Poplin E, et al.: Gemcitabine (G) plasma and intracellular pharmacokinetics in E6201: greater metabolite levels using fixed dosing rate (FDR) delivery. [Abstract] J Clin Oncol 24 (Suppl 18): A-2024, 2006.

  • Poplin E, Levy DE, Berlin J, et al.: Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose-rate infusion[FDR]) versus gemcitabine + oxaliplatin(GEMOX) in patients with advanced pancreatic cancer (E6201). [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA4004, 180s, 2006.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine hydrochloride and oxaliplatin in people with Pancreatic Cancer, run by Eastern Cooperative Oncology Group at 61 sites in 2 countries.

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 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, South Africa. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058149, which also lists 3 linked publications.

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 21 Sep 2011.

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