Completed

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

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What is being tested

filgrastim

+ ifosfamide

+ paclitaxel

BiologicalDrug
Who is being recruted

Neoplasms+1

+ Neoplasms by Histologic Type

+ Neoplasms, Connective and Soft Tissue

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 1997
See protocol details

Summary

Principal SponsorGynecologic Oncology Group
Last updated: July 9, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00003128
Principal SponsorGynecologic Oncology Group
Last updated: July 9, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

166 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective and Soft TissueSarcoma

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

Stanford Cancer Center at Stanford University Medical Center

Stanford, United States

CCOP - Carle Cancer Center

Urbana, United States

Indiana University Cancer Center

Indianapolis, United States
Completed17 Study Centers