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

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ClinicalTrials.gov Identifier: NCT00003128
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 9, 2013
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by:
GOG Foundation

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide alone is more effective than ifosfamide plus paclitaxel in treating patients with cancer of the uterus.

PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of the uterus.


Condition or disease Intervention/treatment Phase
Sarcoma Biological: filgrastim Drug: ifosfamide Drug: paclitaxel Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : November 1997
Actual Primary Completion Date : February 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003128


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Investigators
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Study Chair: Howard D. Homesley, MD Gynecologic Oncology Network
Study Chair: Higinia R. Cardenes, MD, PhD Indiana University Melvin and Bren Simon Cancer Center
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00003128    
Other Study ID Numbers: CDR0000065891
GOG-0161
ECOG-G0161
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: May 2004
Keywords provided by GOG Foundation:
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine carcinosarcoma
Additional relevant MeSH terms:
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Sarcoma
Carcinosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Paclitaxel
Ifosfamide
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents