Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Estimated Enrollment: | 240 |
| Study Start Date: | December 1998 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Hide Study Locations| United States, Alabama | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, California | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033-0800 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Women's Cancer Center | |
| Palo Alto, California, United States, 94304 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| Vincent T. Lombardi Cancer Research Center, Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5265 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21287 | |
| Medicine Branch | |
| Bethesda, Maryland, United States, 20892 | |
| Radiation Oncology Branch | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Massachusetts | |
| Tufts University School of Medicine | |
| Boston, Massachusetts, United States, 02111 | |
| Memorial Hospital | |
| Worcester, Massachusetts, United States, 01605 | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Cooper Hospital/University Medical Center | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| Cancer Center of Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| State University of New York Health Science Center at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| State University of New York Health Sciences Center - Stony Brook | |
| Stony Brook, New York, United States, 11790-9832 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Ohio | |
| Barrett Cancer Center, The University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| University of Oklahoma College of Medicine | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| CCOP - Sooner State | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| CCOP - Baptist Cancer Institute | |
| Memphis, Tennessee, United States, 38117 | |
| Brookview Research, Inc. | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Virginia | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Tacoma General Hospital | |
| Tacoma, Washington, United States, 98405 | |
| Canada, Ontario | |
| NCIC-Clinical Trials Group | |
| Kingston, Ontario, Canada, K7L 3N6 | |
| Study Chair: | Gini F. Fleming, MD | University of Chicago |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003691 History of Changes |
| Other Study ID Numbers: | CDR0000066794, GOG-0177 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 10, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III endometrial carcinoma stage IV endometrial carcinoma recurrent endometrial carcinoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |
Neoplasms, Glandular and Epithelial Cisplatin Doxorubicin Paclitaxel Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013