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

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003691
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 240
• Locations: 73
• Patients Per Site: 3.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Biological: filgrastim; Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: paclitaxel	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 1998
• Actual Primary Completion Date: Jun 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	CCOP - Greater Phoenix	Phoenix	Arizona	United States	85006-2726
3	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033-0800
4	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
5	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
6	Women's Cancer Center	Palo Alto	California	United States	94304
7	University of Colorado Cancer Center	Denver	Colorado	United States	80262
8	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia	United States	20007
9	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
10	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
11	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
12	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
13	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
14	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612
15	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
16	CCOP - Central Illinois	Decatur	Illinois	United States	62526
17	CCOP - Evanston	Evanston	Illinois	United States	60201
18	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5265
19	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
20	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
21	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
22	Johns Hopkins Oncology Center	Baltimore	Maryland	United States	21287
23	Medicine Branch	Bethesda	Maryland	United States	20892
24	Radiation Oncology Branch	Bethesda	Maryland	United States	20892
25	Tufts University School of Medicine	Boston	Massachusetts	United States	02111
26	Memorial Hospital	Worcester	Massachusetts	United States	01605
27	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
28	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
29	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
30	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
31	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
32	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi	United States	39534-2576
33	CCOP - Kansas City	Kansas City	Missouri	United States	64131
34	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
35	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
36	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
37	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
38	Cooper Hospital/University Medical Center	Camden	New Jersey	United States	08103
39	Cancer Center of Albany Medical Center	Albany	New York	United States	12208
40	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
41	North Shore University Hospital	Manhasset	New York	United States	11030
42	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
43	University of Rochester Cancer Center	Rochester	New York	United States	14642
44	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York	United States	11790-9832
45	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
46	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
47	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1082
48	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45219
49	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
50	Cleveland Clinic Cancer Center	Cleveland	Ohio	United States	44195
51	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210
52	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
53	CCOP - Sooner State	Tulsa	Oklahoma	United States	74136
54	CCOP - Columbia River Program	Portland	Oregon	United States	97213
55	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
56	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
57	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
58	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107
59	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
60	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
61	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
62	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
63	CCOP - Greenville	Greenville	South Carolina	United States	29615
64	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
65	CCOP - Baptist Cancer Institute	Memphis	Tennessee	United States	38117
66	Brookview Research, Inc.	Nashville	Tennessee	United States	37203
67	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
68	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030
69	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
70	Cancer Center, University of Virginia HSC	Charlottesville	Virginia	United States	22908
71	University of Washington Medical Center	Seattle	Washington	United States	98195-6043
72	Tacoma General Hospital	Tacoma	Washington	United States	98405
73	NCIC-Clinical Trials Group	Kingston	Ontario	Canada	K7L 3N6

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Gini F. Fleming, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00003691
• Other Study ID Numbers: CDR0000066794; GOG-0177; NCT00698620
• First Posted: Jun 24, 2004
• Last Update Posted: Jul 9, 2013
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: stage III endometrial carcinoma; stage IV endometrial carcinoma; recurrent endometrial carcinoma
• Additional relevant MeSH terms: Endometrial Neoplasms; Paclitaxel; Doxorubicin; Liposomal doxorubicin

Study Results

No Results Posted as of Jul 9, 2013