Clinical trial NCT00003128: Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcoma
Keywords: stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine carcinosarcoma
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Eastern Cooperative Oncology Group
First posted: 2003-01-27
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Stanford
country: United States
facility: Stanford Cancer Center at Stanford University Medical Center
state: California
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Las Vegas
country: United States
facility: CCOP - Southern Nevada Cancer Research Foundation
state: Nevada
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center at Dartmouth Medical School
state: New Hampshire
city: Bronx
country: United States
facility: MBCCOP-Our Lady of Mercy Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Danville
country: United States
facility: CCOP - Geisinger Clinic and Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Temple
country: United States
facility: CCOP - Scott and White Hospital
state: Texas
Study officials:
affiliation: Gynecologic Oncology Network
name: Howard D. Homesley, MD
role: STUDY_CHAIR
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: Higinia R. Cardenes, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.