Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus
Condition: Uterine Cancer
MeSH terms: Uterine Neoplasms; Mixed Tumor, Mesodermal
Intervention: Ifosfamide; Radiation Therapy; Cisplatin
Intervention description: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg/IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.; Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg /IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.; dosage is 20 mg/m2/day for 5 days, ever 3 weeks.
Intervention MeSH terms: Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mixed Mesodermal Tumor; MMT; Uterine Cancer; Radiation Therapy; Chemotherapy

Summary:

      The optimal sequence and /or modality for adjuvant therapy in the management of Mixed
      Mesodermal Tumors (MMT) clearly remains to be established. The rationale for the protocol is
      to "sandwich" pelvic radiation with chemotherapy to decrease distant metastasis.

      The proposed study will sandwich radiation between the two most active chemotherapeutic
      agents for MMT identified to date (ifosfamide/cisplatin). By doing so, we attempt to decrease
      both local and distant recurrence, which may translate into an improved progression free
      interval and possibly even extend survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented mixed mesodermal tumor (MMT) of uterus with no visible
             residual disease.

          -  Surgical staging to include total abdominal hysterectomy, bilateral
             salpingo-oophorectomy, peritoneal washings, and lymph node sampling.

          -  Surgical staging should be completed 6 weeks ± 7 days prior to enrollment.

          -  Age >= 18 years.

          -  Written voluntary informed consent.

        Exclusion Criteria:

          -  Patient has impairment of hepatic, renal or hematologic function as defined by the
             following baseline laboratory values:

               -  Total serum bilirubin >1.5mg/dl

               -  History of chronic or active hepatitis

               -  Serum creatinine >2.0 mg/dl

               -  Platelets <100,000/mm3

               -  Absolute neutrophil count (ANC) <1500/mm3

               -  Hemoglobin <8.0 g/dl (the patient may be transfused prior to study entry)

          -  Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes,
             unstable angina, myocardial infarction within 6 months, congestive heart failure,
             etc.)

          -  Patient has been treated with myelosuppressive chemotherapy within three weeks prior
             to study entry.

          -  Patients with any prior chemotherapy or radiotherapy for pelvic malignancy.

          -  Patients with dementia or altered mental status that would prohibit the giving and
             understanding of informed consent at time of study entry.

          -  Patient has a uterine sarcoma other then mixed mesodermal tumor (MMT).