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Phase III Randomized Study of Ifosfamide with or without Paclitaxel in Patients with Advanced, Refractory, or Recurrent Carcinosarcoma of the Uterus
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 | Protocol IDs |
---|
Phase III | Treatment | Completed | 18 and over | GOG-0161 ECOG-G0161, NCT00003128 |
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.
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: Chemotherapy: - No prior chemotherapy for carcinosarcoma of the
uterus
Endocrine therapy: Radiotherapy: - At least 6 weeks since radiotherapy for current
malignancy
- At least 3 months since radiotherapy if delivered to site of
measurable disease
Surgery: Patient Characteristics:
Age: Performance status: Life expectancy: 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 166A 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. Published ResultsHomesley 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 ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | Howard Homesley, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) |
Eastern Cooperative Oncology Group ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | Higinia Cardenes, MD, PhD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) |
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | 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 | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 1997-11-17 | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2009-01-25 | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00003128 | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 1997-10-28 | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2004-05-10 | ![](https://webarchive.library.unt.edu/eot2008/20090514230611im_/http://www.cancer.gov/images/spacer.gif) | NCI Grant/Contract Number | | CA27469 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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