Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer
Condition: Sarcoma
MeSH terms: Sarcoma; Carcinosarcoma
Intervention: carboplatin; paclitaxel
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; uterine carcinosarcoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin
      works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor)

               -  Stage III or IV disease

               -  Persistent or recurrent disease

          -  Documented disease progression

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

               -  At least 1 target lesion

                    -  Tumors within a previously irradiated field are not considered target
                       lesions unless there is documented disease progression

          -  Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any
             active GOG phase III protocol for the same patient population)

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  GOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  SGOT ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection requiring antibiotics

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

          -  No sensory or motor neuropathy > grade 1

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior cytotoxic chemotherapy for uterine sarcoma

        Endocrine therapy

          -  At least 1 week since prior hormonal therapy for uterine sarcoma

          -  Concurrent hormone replacement therapy allowed

        Radiotherapy

          -  See Disease Characteristics

        Surgery

          -  Not specified

        Other

          -  Recovered from all prior therapy

          -  No prior anticancer therapy that would preclude study therapy