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

Sponsors and Collaborators:	Gynecologic Oncology Group 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:	Treatment, Randomized
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: Cancer Soft Tissue Sarcoma Uterine Cancer

Drug Information available for: Paclitaxel Filgrastim Ifosfamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	166
Study Start Date:	November 1997
Primary Completion Date:	January 2009 (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
Genders 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

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
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
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
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR. 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.

Study ID Numbers:	CDR0000065891, GOG-0161, ECOG-G0161
Study First Received:	November 1, 1999
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00003128 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Antimitotic Agents
Recurrence
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Ifosfamide
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
Paclitaxel

Mechlorethamine
Uterine Sarcoma
Tubulin Modulators
Sarcoma
Uterine Neoplasms
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Carcinosarcoma
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Antimitotic Agents
Pharmacologic Actions
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms

Ifosfamide
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Sarcoma
Uterine Neoplasms
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Isophosphamide mustard

ClinicalTrials.gov processed this record on July 02, 2009