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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003128 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide alone is more effective than ifosfamide plus paclitaxel in treating patients with cancer of the uterus.
PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of the uterus.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: filgrastim Drug: ifosfamide Drug: paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III Trial of Ifosfamide (NSC #109274) Versus Ifosfamide Plus Paclitaxel (NSC #125973) in Patients With Advanced, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus |
| Estimated Enrollment: | 166 |
| Study Start Date: | November 1997 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to GOG performance status (GOG 0-1 vs GOG 2-3) and randomized to one of two treatment arms.
Treatment for both arms continues for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, then every 6 months for an additional 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 166 patients (83 per arm) will be accrued for this study within approximately 5.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have measurable disease consisting of abdominal, pelvic, chest or other masses that can be defined in at least 2 dimensions by palpation, x-ray, MRI, computed tomography or ultrasound
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, California | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305-5216 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth Medical School | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New York | |
| MBCCOP-Our Lady of Mercy Cancer Center | |
| Bronx, New York, United States, 10466 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Abramson Cancer Center at University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Study Chair: | Howard D. Homesley, MD | Gynecologic Oncology Network |
| Study Chair: | Higinia R. Cardenes, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00003128 History of Changes |
| Other Study ID Numbers: | CDR0000065891, GOG-0161, ECOG-G0161 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 13, 2009 |
| Health Authority: | United States: Federal Government |
|
stage III uterine sarcoma stage IV uterine sarcoma recurrent uterine sarcoma uterine carcinosarcoma |
|
Carcinosarcoma Uterine Neoplasms Sarcoma Neoplasms, Complex and Mixed Neoplasms by Histologic Type Neoplasms Neoplasms, Connective and Soft Tissue Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Ifosfamide Isophosphamide mustard Paclitaxel |
Lenograstim Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
