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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003128
• Other study ID #: CDR0000065891
• Secondary ID: GOG-0161ECOG-G01
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 8, 2013
• Start date: November 1997

Study information

• Verified date: May 2004
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Biological:
• filgrastim

Drug:
• ifosfamide

• paclitaxel

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	MBCCOP-Our Lady of Mercy Cancer Center	Bronx	New York
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	Indiana University Cancer Center	Indianapolis	Indiana
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	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Stanford Cancer Center at Stanford University Medical Center	Stanford	California
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Carle Cancer Center	Urbana	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 On — View Citation