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 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 9, 2013
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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 |
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 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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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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
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
Show 17 study locations
| Study Chair: | Howard D. Homesley, MD | Gynecologic Oncology Network | |
| Study Chair: | Higinia R. Cardenes, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
| 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 |
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stage III uterine sarcoma stage IV uterine sarcoma recurrent uterine sarcoma uterine carcinosarcoma |
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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 |