Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus - Full Text View

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 3


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

Resource links provided by NLM:

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Ifosfamide Paclitaxel

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Malignant Mixed Mullerian Tumor Uterine Carcinosarcoma Uterine Sarcoma

U.S. FDA Resources

Further study details as provided by Gynecologic Oncology Group:


Estimated Enrollment:	166
Study Start Date:	November 1997
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003128

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

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Investigators


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

Publications:

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.


ClinicalTrials.gov Identifier:	NCT00003128 History of Changes
Other Study ID Numbers:	CDR0000065891 GOG-0161 ECOG-G0161
Study First Received:	November 1, 1999
Last Updated:	July 8, 2013

Keywords provided by Gynecologic Oncology Group:


stage III uterine sarcoma stage IV uterine sarcoma recurrent uterine sarcoma uterine carcinosarcoma

Additional relevant MeSH terms:


Sarcoma Carcinosarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Complex and Mixed Paclitaxel Isophosphamide mustard Albumin-Bound Paclitaxel	Ifosfamide Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents

ClinicalTrials.gov processed this record on July 24, 2017