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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

Phase 3
18 Years
Not Enrolling

Thank you

Trial Information

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


- 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.

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



- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Albumin at least 3 g/dL

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal


- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 50 mL/min


- No history of congestive heart failure

- No unstable angina

- No myocardial infarction within the past 6 months


- No septicemia

- No severe infection

- No acute hepatitis

- No gastrointestinal bleeding

- At least 5 years since any other invasive malignancy except nonmelanoma skin cancer


Biologic therapy:

- Not specified


- No prior chemotherapy for carcinosarcoma of the uterus

Endocrine therapy:

- Not specified


- At least 6 weeks since radiotherapy for current malignancy

- At least 3 months since radiotherapy if delivered to site of measurable disease


- Not specified

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Howard D. Homesley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Network


United States: Federal Government

Study ID:




Start Date:

November 1997

Completion Date:

Related Keywords:

  • Sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • uterine carcinosarcoma
  • Carcinosarcoma
  • Uterine Neoplasms
  • Sarcoma



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Ochsner New Orleans, Louisiana  70121
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
CCOP - Scott and White Hospital Temple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Tufts - New England Medical Center Boston, Massachusetts  02111
Stanford Cancer Center at Stanford University Medical Center Stanford, California  94305
Norris Cotton Cancer Center at Dartmouth Medical School Lebanon, New Hampshire  03756-0002
MBCCOP-Our Lady of Mercy Cancer Center Bronx, New York  10466
Abramson Cancer Center at University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104