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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003691
• Other study ID #: CDR0000066794
• Secondary ID: GOG-0177
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 8, 2013
• Start date: December 1998

Study information

• Verified date: September 2010
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.

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.

Other known NCT identifiers

• NCT00698620

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

Biological:
• filgrastim

Drug:
• cisplatin

• doxorubicin hydrochloride

• paclitaxel

Locations

Country	Name	City	State
Canada	NCIC-Clinical Trials Group	Kingston	Ontario
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	Medicine Branch	Bethesda	Maryland
United States	Radiation Oncology Branch	Bethesda	Maryland
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Tufts University School of Medicine	Boston	Massachusetts
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cancer Center, University of Virginia HSC	Charlottesville	Virginia
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	CCOP - Central Illinois	Decatur	Illinois
United States	University of Colorado Cancer Center	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Greenville	Greenville	South Carolina
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	CCOP - Baptist Cancer Institute	Memphis	Tennessee
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Women's Cancer Center	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	CCOP - Columbia River Program	Portland	Oregon
United States	University of Rochester Cancer Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Tacoma General Hospital	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Sooner State	Tulsa	Oklahoma
United States	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	Memorial Hospital	Worcester	Massachusetts
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (10)

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. — View Citation

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 Gr — View Citation

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. [Abstra

Grushko TA, Filiaci VL, Mundt AJ, Ridderstråle 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. 2 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. Epub 2006 Dec 5. — View Citation

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. — View Citation