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Endometrial CancerPhase 3NCT00003691

Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

A Phase 3 study testing filgrastim, cisplatin and doxorubicin hydrochloride in people with Endometrial Cancer, run by Gynecologic Oncology Group at 73 sites in 2 countries.

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 cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
filgrastim, cisplatin and doxorubicin hydrochloride
How many people
240 participants
Where
73 sitesin 2 countries
Study dates
Dec 1998to Jun 2004
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary stage III, stage IV, or recurrent endometrial carcinoma
  • Very poor potential for cure by radiotherapy or surgery alone or in combination
  • Measurable disease
  • Disease in an irradiated field as the only site of measurable disease allowed provided there has been clear progression since completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Granulocyte count at least 1,500/mm^3

Hepatic

  • SGPT no greater than 3 times upper limit of normal
  • Bilirubin normal

Renal

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular

  • LVEF at least 50% within past 6 months
  • No uncontrolled angina
  • No third-degree or complete heart block unless a pacemaker is in place

Neurologic

  • No serious peripheral neuropathy

Other

  • No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer
  • No uncontrolled infection
  • No sensitivity to E. coli-derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed
  • No concurrent biologic therapy

Chemotherapy

  • No prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization
  • No prior chemotherapy for any prior malignancy

Endocrine therapy

  • Prior hormone therapy allowed
  • No concurrent hormone therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the spine

Surgery

  • Not specified

Trial locations and contacts

73 sites in 2 countries.

73 sites in 2 countries

United States72 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21287

  • Medicine Branch

    Bethesda, Maryland, 20892

  • Radiation Oncology Branch

    Bethesda, Maryland, 20892

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Tufts University School of Medicine

    Boston, Massachusetts, 02111

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • Cooper Hospital/University Medical Center

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia, 22908

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45219

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio, 44195

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Baptist Cancer Institute

    Memphis, Tennessee, 38117

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Brookview Research, Inc.

    Nashville, Tennessee, 37203

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73190

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Women's Cancer Center

    Palo Alto, California, 94304

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-9832

  • Tacoma General Hospital

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - Sooner State

    Tulsa, Oklahoma, 74136

  • Vincent T. Lombardi Cancer Research Center, Georgetown University

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • Memorial Hospital

    Worcester, Massachusetts, 01605

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada1 site

  • NCIC-Clinical Trials Group

    Kingston, Ontario, K7L 3N6

Other trials in Canada

About this study

Official title: A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.

Read the detailed description

OBJECTIVES:

  • Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma.
  • Compare the toxicities of these two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour.
  • Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days.

Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.

Keywords
stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma
Medical subject headings
Endometrial 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 posted24 Jun 2004 (estimated)
  2. Study startDec 1998
  3. Primary completionJun 2004

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
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003691
Sponsor's protocol ID
CDR0000066794
Other IDs
GOG-0177
Status last verified
Sep 2010
First submitted
1 Nov 1999
Last updated
9 Jul 2013
Results posted
No

Publications

  • Farley JH, Tian C, Rose GS, Brown CL, Birrer M, Risinger JI, Thigpen JT, Fleming GF, Gallion HH, Maxwell GL. Chemotherapy intensity and toxicity among black and white women with advanced and recurrent endometrial cancer: a Gynecologic Oncology Group Study. Cancer. 2010 Jan 15;116(2):355-61. doi: 10.1002/cncr.24769.

    PubMed 19924790

  • Moore KN, Tian C, McMeekin DS, Thigpen JT, Randall ME, Gallion HH. Does the progression-free interval after primary chemotherapy predict survival after salvage chemotherapy in advanced and recurrent endometrial cancer?: a Gynecologic Oncology Group ancillary data analysis. Cancer. 2010 Dec 1;116(23):5407-14. doi: 10.1002/cncr.25480. Epub 2010 Aug 24.

    PubMed 20737572

  • McMeekin DS, Filiaci VL, Thigpen JT, Gallion HH, Fleming GF, Rodgers WH; Gynecologic Oncology Group study. The relationship between histology and outcome in advanced and recurrent endometrial cancer patients participating in first-line chemotherapy trials: a Gynecologic Oncology Group study. Gynecol Oncol. 2007 Jul;106(1):16-22. doi: 10.1016/j.ygyno.2007.04.032.

    PubMed 17574073

  • Modesitt SC, Tian C, Kryscio R, Thigpen JT, Randall ME, Gallion HH, Fleming GF; Gynecologic Oncology Group. Impact of body mass index on treatment outcomes in endometrial cancer patients receiving doxorubicin and cisplatin: a Gynecologic Oncology Group study. Gynecol Oncol. 2007 Apr;105(1):59-65. doi: 10.1016/j.ygyno.2006.10.045. Epub 2006 Dec 5.

    PubMed 17150247

  • Maxwell GL, Tian C, Risinger J, Brown CL, Rose GS, Thigpen JT, Fleming GF, Gallion HH, Brewster WR; Gynecologic Oncology Group study. Racial disparity in survival among patients with advanced/recurrent endometrial adenocarcinoma: a Gynecologic Oncology Group study. Cancer. 2006 Nov 1;107(9):2197-205. doi: 10.1002/cncr.22232.

    PubMed 17001661

  • Modesitt S, Tian C, Kryscio R, et al.: Impact of body mass index (BMI) on treatment outcomes in advanced or recurrent endometrial cancer patients receiving doxorubicin/cisplatin chemotherapy: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-93, 2006.

  • Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. doi: 10.1200/JCO.2004.07.184.

    PubMed 15169803

  • Fleming GF, Brunetto VL, Mundt AJ, et al.: Randomized trial of doxorubicin (DOX) plus cisplatin (CIS) versus DOX plus CIS plus paclitaxel (TAX) in patients with advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group (GOG) study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-807, 2002.

  • Huang HQ, Brady MF, Cella D, Fleming G. Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study. Int J Gynecol Cancer. 2007 Mar-Apr;17(2):387-93. doi: 10.1111/j.1525-1438.2007.00794.x.

    PubMed 17362317

  • Grushko TA, Filiaci VL, Mundt AJ, Ridderstrale K, Olopade OI, Fleming GF; Gynecologic Oncology Group. An exploratory analysis of HER-2 amplification and overexpression in advanced endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Jan;108(1):3-9. doi: 10.1016/j.ygyno.2007.09.007. Epub 2007 Oct 18.

    PubMed 17945336

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, cisplatin and doxorubicin hydrochloride in people with Endometrial Cancer, run by Gynecologic Oncology Group at 73 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 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada. 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 NCT00003691, which also lists 10 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 9 Jul 2013.

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