Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	GOG-0161 ECOG-G0161, NCT00003128

Objectives

1. 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.
2. Determine the toxicity of ifosfamide with paclitaxel in these patients.

Entry 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

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

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

Expected Enrollment

A total of 166 patients (83 per arm) will be accrued for this study within approximately 5.5 years.

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.

Homesley HD, Filiaci V, Markman M, et al.: Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group Study. J Clin Oncol 25 (5): 526-31, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Howard Homesley, MD, Protocol chair		Ph: 252-756-5388 Email: hdh7173@aol.com

Eastern Cooperative Oncology Group

Higinia Cardenes, MD, PhD, Protocol chair		Ph: 317-274-2524; 888-600-4822 Email: hcardene@iupui.edu

Registry Information
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
Trial Start Date		1997-11-17
Trial Completion Date		2009-01-25
Registered in ClinicalTrials.gov		NCT00003128
Date Submitted to PDQ		1997-10-28
Information Last Verified		2004-05-10
NCI Grant/Contract Number		CA27469