Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI GOG-0209 NCT00063999

Special Category: CTSU trial, NCI Web site featured trial

Objectives

1. Compare the efficacy of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs carboplatin and paclitaxel, in terms of survival, in patients with stage III or IV or recurrent endometrial cancer.
2. Determine whether estrogen/progesterone receptor status provides prognostic information in patients treated with these regimens.
3. Compare the toxicity profile of these regimens, specifically neurotoxicity and infection, in these patients.
4. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed endometrial carcinoma
  • FIGO stage III or IV or recurrent disease



• Must know estrogen and progesterone status of the primary tumor



• Poor potential for curative treatment by radiotherapy and/or surgery



• At least 1 unidimensionally measurable lesion (for patients with stage III disease only)
  • At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR at least 10 mm by spiral CT scan
  • Disease in a previously irradiated field acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy

Prior/Concurrent Therapy:

Biologic therapy

• Prior biologic therapy allowed
• No concurrent biologic therapy

Chemotherapy

• No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or any other malignancy

Endocrine therapy

• Prior hormonal therapy allowed
• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the spine
• No concurrent radiotherapy

Surgery

• Not specified

Other

• Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

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

Renal

• Creatinine no greater than 1.6 mg/dL

Cardiovascular

• LVEF at least 50%
• Cardiac conduction abnormalities or dysfunction allowed at the investigator's discretion
• No third-degree or complete heart block without a pacemaker
• No uncontrolled angina
• No myocardial infarction within the past 6 months
• No New York Heart Association class II -IV heart failure
• No symptoms of congestive heart failure

Other

• Not pregnant or nursing
• Fertile patients must use effective non-hormonal contraception during and for at least 2 months after study participation
• No other invasive malignancy within the past 5 years except patients who have nonmelanoma skin cancer or have received prior chemotherapy for that malignancy
• No serious uncontrolled infection
• No serious peripheral neuropathy
• No other concurrent medical illness that would preclude study therapy
• No circumstances that would preclude study completion or follow-up
• No sensitivity to Escherichia coli-derived drug preparations
• No uterine carcinosarcoma or other non-epithelial uterine malignancy

Expected Enrollment

A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years.

Outcomes

Duration of overall survival

Duration of progression-free survival

Outline

This is a randomized, multicenter study. Patients accrued as of 04/17/06 are stratified according to disease status(measurable or recurrent disease vs non-measurable stage III or IV disease with pelvic radiotherapy vs non-measurable stage III or IV disease without pelvic radiotherapy). Patients are randomized to 1 of 2 treatment arms. Patients with LVEF < 50% at randomization who are initially randomized to arm I are immediately crossed over to arm II.

• Arm I: Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12.



• Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.

In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 6, 15, and 26 of study therapy.

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

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

David Miller, MD, Protocol chair		Ph: 214-648-3026; 866-460-4673 Email: david.miller@utsouthwestern.edu

U.S.A.
Alabama
	Birmingham
	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
		Clinical Trials Office - Lurleen Wallace Comprehensive Cancer	Ph:  205-934-0309
	Huntsville
	Clearview Cancer Institute
		Clinical Trials Office - Clearview Cancer Institute	Ph:  256-705-4224
	Mobile
	Providence Cancer Center at Providence Hospital
		Paul Schwarzenberger, MD	Ph:  251-544-1013
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Concord
	Cancer Care Center at John Muir Health - Concord Campus
		Clinical Trials Office - Cancer Care Center at John Muir Health - Concord Campus	Ph:  925-674-2580
	Fremont
	Kaiser Permanente - Fremont
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Hayward
	Kaiser Permanente Medical Center - Hayward
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Long Beach
	Todd Cancer Institute at Long Beach Memorial Medical Center
		Krishnansu Tewari	Ph:  562-933-0900
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719
	Kaiser Permanente Medical Center - Los Angeles
		Scott Lentz, MD	Ph:  323-783-4018
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Ilana Cass	Ph:  310-423-3277
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	Modesto
	Memorial Medical Center
		Clinical Trials Office - Memorial Medical Center	Ph:  209-572-7116
	Oakland
	Kaiser Permanente Medical Center - Oakland
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Center	Ph:  877-UC-STUDY
			Email: ucstudy@uci.edu
	Redwood City
	Kaiser Permanente Medical Center - Redwood City
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Richmond
	Kaiser Permanente Medical Center - Richmond
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Roseville
	Kaiser Permanente Medical Center - Roseville
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Sacramento
	Kaiser Permanente Medical Center - Sacramento
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	South Sacramento Kaiser-Permanente Medical Center
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Salinas
	Salinas Valley Memorial Hospital
		Shehzad Aziz, MD	Ph:  831-755-1701
	San Francisco
	Kaiser Permanente Medical Center - San Francisco Geary Campus
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	San Jose
	Kaiser Permanente Medical Center - Santa Teresa
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	San Rafael
	Kaiser Foundation Hospital - San Rafael
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Santa Clara
	Kaiser Permanente Medical Center - Santa Clara Kiely Campus
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Santa Rosa
	Kaiser Permanente Medical Center - Santa Rosa
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	South San Francisco
	Kaiser Permanente Medical Center - South San Francisco
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Stockton
	Kaiser Permanente Medical Facility - Stockton
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Sylmar
	Olive View - UCLA Medical Center Foundation
		Christine Holschneider, MD	Ph:  310-206-5161
	Vallejo
	Kaiser Permanente Medical Center - Vallejo
		Louis Fehrenbacher, MD	Ph:  707-651-2577
	Walnut Creek
	John Muir/Mt. Diablo Comprehensive Cancer Center
		Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Cancer Center	Ph:  925-941-4246
	Kaiser Permanente Medical Center - Walnut Creek
		Louis Fehrenbacher, MD	Ph:  707-651-2577
Colorado
	Aurora
	Colorado Gynecologic Oncology Group, PC
		Susan Davidson, MD	Ph:  303-315-7897
	Fort Collins
	Front Range Cancer Specialists
		Diana Medgyesy, MD	Ph:  970-212-7600
	Poudre Valley Hospital
		Clinical Trials Office - Poudre Valley Hospital	Ph:  970-495-8226
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Clinical Trials Office - George Bray Cancer Center	Ph:  860-224-5660
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
District of Columbia
	Washington
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
	Washington Cancer Institute at Washington Hospital Center
		Clinical Trials Office - Washington Cancer Institute	Ph:  202-877-8839
Florida
	Clearwater
	Morton Plant Hospital
		Hector Arango, MD	Ph:  727-446-2111
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Clinical Trials Office - Broward General Medical Center Cancer Center	Ph:  954-355-5346
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	St. Vincent's Medical Center
		William Thompson, Jr.	Ph:  904-308-7300
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Alan Gordon	Ph:  407-648-3800 800-648-3818
	Sarasota
	Sarasota Memorial Hospital
		Clinical Trials Office - Sarasota Memorial Hospital	Ph:  941-917-2225
	West Palm Beach
	Palm Beach Cancer Institute - West Palm Beach
		John Rinehart	Ph:  561-366-4117
Georgia
	Augusta
	MBCCOP - Medical College of Georgia Cancer Center
		Sharad Ghamande, MD	Ph:  706-721-3992
	Columbus
	John B. Amos Cancer Center
		Clinical Trials Office - John B. Amos Cancer Center	Ph:  706-660-6404
	Gainesville
	Northeast Georgia Medical Center
		Richard LoCicero, MD	Ph:  770-297-5700
	Macon
	Central Georgia Gynecologic Oncology
		Gary Eddy, MD	Ph:  476-633-6090
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Hawaii
	Aiea
	Kapiolani Medical Center at Pali Momi
		Michael Carney, MD	Ph:  808-983-6090
	Honolulu
	Hawaii Medical Center - East
		Michael Carney, MD	Ph:  808-983-6090
	Kapiolani Medical Center for Women and Children
		Michael Carney, MD	Ph:  808-983-6090
	MBCCOP - Hawaii
		Michael Carney, MD	Ph:  808-983-6090
	OnCare Hawaii, Incorporated - Kuakini
		Michael Carney, MD	Ph:  808-983-6090
	OnCare Hawaii, Incorporated - Lusitana
		Michael Carney, MD	Ph:  808-983-6090
	Queen's Cancer Institute at Queen's Medical Center
		Michael Carney, MD	Ph:  808-983-6090
	Straub Clinic and Hospital, Incorporated
		Michael Carney, MD	Ph:  808-983-6090
	Wailuku
	Pacific Cancer Institute - Maui
		Michael Carney, MD	Ph:  808-983-6090
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Jefferson Upshaw	Ph:  618-465-2571
	Arlington Heights
	Northwest Community Hospital
		Josh Tunca, MD	Ph:  847-358-2009
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3019
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3605
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
	Rush University Medical Center
		Clinical Trials Office - Rush University Medical Center	Ph:  312-942-5498
			Email: clinical_trials@rush.edu
	Swedish Covenant Hospital
		K. Joseph Philip, MD	Ph:  773-784-6676
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Evanston
	Evanston Northwestern Healthcare - Evanston Hospital
		Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital	Ph:  847-570-1381
	St. Francis Hospital
		K. Joseph Philip, MD	Ph:  773-784-6676
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3605
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3605
	Havana
	Mason District Hospital
		John Kugler, MD	Ph: