Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
NCT ID: NCT00003128
Last Updated: 2013-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
166 participants
INTERVENTIONAL
1997-11-30
Brief Summary
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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.
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Detailed Description
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* Determine whether the addition of paclitaxel to ifosfamide improves length of survival, progression free interval and response rate when compared to ifosfamide alone in patients with advanced, refractory or recurrent carcinosarcoma (mixed mesodermal tumors) of the uterus.
* Determine the toxicity of ifosfamide with paclitaxel in these patients.
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.
* Arm I: Patients receive ifosfamide IV daily for 3 days every 21 days.
* Arm II: Patients receive paclitaxel IV on day 1 and ifosfamide IV on days 1-3 every 21 days. Filgrastim (G-CSF) is given subcutaneously beginning on day 4 until granulocyte count is greater than 2,000/mm3. Paclitaxel therapy may precede or be given concurrently with ifosfamide.
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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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filgrastim
ifosfamide
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed stage III or IV, refractory, or recurrent heterologous or homologous carcinosarcoma (mixed mesodermal tumors) of the uterus
* Must not be amenable to curative-intent therapy
* 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
* If measured by MRI, computed tomography or ultrasound, the lesion must have a minimal tumor measurement of 1 cm
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:
* Albumin at least 3 g/dL
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* No history of congestive heart failure
* No unstable angina
* No myocardial infarction within the past 6 months
Other:
* No septicemia
* No severe infection
* No acute hepatitis
* No gastrointestinal bleeding
* At least 5 years since any other invasive malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for carcinosarcoma of the uterus
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 6 weeks since radiotherapy for current malignancy
* At least 3 months since radiotherapy if delivered to site of measurable disease
Surgery:
* Not specified
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Howard D. Homesley, MD
Role: STUDY_CHAIR
Gynecologic Oncology Network
Higinia R. Cardenes, MD, PhD
Role: STUDY_CHAIR
Indiana University Melvin and Bren Simon Cancer Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, United States
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Countries
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References
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Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 10;25(5):526-31. doi: 10.1200/JCO.2006.06.4907.
Other Identifiers
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GOG-0161
Identifier Type: -
Identifier Source: secondary_id
ECOG-G0161
Identifier Type: -
Identifier Source: secondary_id
CDR0000065891
Identifier Type: -
Identifier Source: org_study_id
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