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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Ifosfamide; Isophosphamide mustard; Paclitaxel

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