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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
N/A
Not Enrolling
Female
Sarcoma

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Howard D. Homesley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Network

Authority:

United States: Federal Government

Study ID:

CDR0000065891

NCT ID:

NCT00003128

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

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - OchsnerNew Orleans, Louisiana  70121
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Tufts - New England Medical CenterBoston, Massachusetts  02111
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Norris Cotton Cancer Center at Dartmouth Medical SchoolLebanon, New Hampshire  03756-0002
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104