Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
Condition: Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma
MeSH terms: Carcinosarcoma; Mixed Tumor, Mullerian; Recurrence
Intervention: Gemcitabine Hydrochloride; Docetaxel
Intervention description: Given IV; Given IV
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving gemcitabine together with docetaxel works in
      treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy,
      such as gemcitabine and docetaxel, 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed uterine carcinosarcoma

               -  Malignant mixed Müllerian tumor, homologous or heterologous type

               -  Recurrent or persistent disease

                    -  Progressive disease after prior local therapy

          -  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
                  except documented progression or biopsy to confirm persistence at least 90 days
                  after completion of radiation therapy

          -  Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma

               -  Initial treatment may have included high-dose therapy, consolidation, or extended
                  therapy administered after surgical or non-surgical assessment

          -  Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol
             for the same patient population)

          -  Performance status - GOG 0-2

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 1.5 times upper limit normal (ULN)

          -  SGOT ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  No severe pulmonary disease requiring oxygen supplementation

          -  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 neuropathy (sensory or motor) > grade 1

          -  At least 3 weeks since prior biologic therapy or immunotherapy for the malignancy

          -  No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal
             antibodies, cytokines, or small molecule inhibitors of signal transduction) for
             recurrent or persistent disease

          -  Recovered from prior chemotherapy

          -  No more than 1 prior cytotoxic chemotherapy regimen, either as a single agent or
             combination therapy

          -  No prior docetaxel or gemcitabine

          -  At least 1 week since prior hormonal therapy for the malignancy

          -  Concurrent hormone replacement therapy allowed

          -  Recovered from prior radiotherapy

          -  Recovered from prior surgery

          -  At least 3 weeks since other prior therapy for the malignancy

          -  No prior cancer treatment that would preclude study therapy