Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer
Condition: Mixed Mesodermal (Mullerian) Tumor; Ovarian Carcinosarcoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Stage I Ovarian Cancer AJCC v6 and v7; Stage IA Fallopian Tube Cancer AJCC v6 and v7; Stage IA Ovarian Cancer AJCC v6 and v7; Stage IA Uterine Sarcoma AJCC v7; Stage IB Fallopian Tube Cancer AJCC v6 and v7; Stage IB Ovarian Cancer AJCC v6 and v7; Stage IB Uterine Sarcoma AJCC v7; Stage IC Fallopian Tube Cancer AJCC v6 and v7; Stage IC Ovarian Cancer AJCC v6 and v7; Stage IC Uterine Sarcoma AJCC v7; Stage II Ovarian Cancer AJCC v6 and v7; Stage IIA Fallopian Tube Cancer AJCC v6 and v7; Stage IIA Ovarian Cancer AJCC V6 and v7; Stage IIA Uterine Sarcoma AJCC v7; Stage IIB Fallopian Tube Cancer AJCC v6 and v7; Stage IIB Ovarian Cancer AJCC v6 and v7; Stage IIB Uterine Sarcoma AJCC v7; Stage IIC Fallopian Tube Cancer AJCC v6 and v7; Stage IIC Ovarian Cancer AJCC v6 and v7; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIIA Ovarian Cancer AJCC v6 and v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage IIIA Uterine Sarcoma AJCC v7; Stage IIIB Fallopian Tube Cancer AJCC v7; Stage IIIB Ovarian Cancer AJCC v6 and v7; Stage IIIB Primary Peritoneal Cancer AJCC v7; Stage IIIB Uterine Sarcoma AJCC v7; Stage IIIC Fallopian Tube Cancer AJCC v7; Stage IIIC Ovarian Cancer AJCC v6 and v7; Stage IIIC Primary Peritoneal Cancer AJCC v7; Stage IIIC Uterine Sarcoma AJCC v7; Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7; Stage IVA Uterine Sarcoma AJCC v7; Stage IVB Uterine Sarcoma AJCC v7; Uterine Carcinosarcoma
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Sarcoma; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinosarcoma; Mixed Tumor, Mullerian; Recurrence
Intervention: Carboplatin; Ifosfamide; Paclitaxel; Quality-of-Life Assessment
Intervention description: Given IV; Given IV; Given IV; Ancillary studies
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel; Ifosfamide; Isophosphamide mustard
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 637.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies paclitaxel and carboplatin see how well they work
      compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or
      peritoneal cavity cancer that is newly diagnosed, persistent, or has come back (recurrent).
      Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in
      different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. It is not yet known whether
      paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients
      with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have newly diagnosed stage I-IV, persistent or recurrent (including
             unstaged) uterine carcinosarcoma (malignant mixed mullerian tumor-MMMT or with
             ovarian, fallopian tube or peritoneal carcinosarcoma and an enrollment date prior to
             10/21/2013; pathology confirmed by site/institutional pathologist prior to enrollment)
             and be chemotherapy naïve as directed against their carcinosarcoma; unstaged patients
             (patients who have not had hysterectomy or ovarian surgery) are eligible and should be
             included as "unstaged" if the only histologic (pathology) documentation of the disease
             is a biopsy or curettage of the uterus; if these patients have documented metastatic
             disease, it should be assigned the appropriate stage (III/IV)

          -  Patients may have received prior adjuvant external beam radiation therapy and/or
             vaginal brachytherapy; patients should be at least 4 weeks from the completion of
             external beam radiotherapy prior to beginning protocol chemotherapy; patients do not
             need to be delayed if receiving vaginal brachytherapy only

          -  Gynecologic Oncology Group (GOG) performance status 0, 1, or 2

          -  Patients must have recovered from the effects of recent surgery, radiotherapy, or
             other therapy

          -  Patients must be free of active infection requiring antibiotics

          -  Any hormonal therapy directed at the malignant tumor must be discontinued at least one
             week prior to beginning protocol chemotherapy; continuation of hormone replacement
             therapy is permitted

          -  Platelet count greater than or equal to 100,000/mcL

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL equivalent to
             Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 grade 1

          -  Creatinine less than or equal to 1.5 times upper limit of normal (ULN), CTCAE v3.0
             grade 1

          -  Bilirubin less than or equal to 1.5 times ULN (CTCAE v3.0 grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 times ULN
             (CTCAE v3.0 grade 1)

          -  Alkaline phosphatase less than or equal to 2.5 times ULN (CTCAE v3.0 grade 1)

          -  Serum albumin should be equal to or greater than 3 g/dL

          -  Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             study entry and be practicing an effective form of contraception

          -  Patients may have measurable disease or non-measurable disease; measurable disease is
             defined as at least one lesion that can be accurately measured in at least one
             dimension (longest dimension to be recorded); each lesion must be >= 20 mm when
             measured by conventional techniques, including palpation, plain x-ray, computed
             tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by
             spiral CT; measurable disease patients must have at least one "target lesion" to be
             used to assess progression on this protocol as defined by Response Evaluation Criteria
             In Solid Tumors (RECIST); tumors within a previously irradiated field will be
             designated as "non-target" lesions unless progression is documented or a biopsy is
             obtained to confirm persistence at least 90 days following completion of radiation
             therapy

        Exclusion Criteria:

          -  Patients who have received prior cytotoxic chemotherapy for management of uterine or
             ovarian carcinosarcoma

          -  Patients with a history of other invasive malignancies or with a concomitant invasive
             malignancy, with the exception of non-melanoma skin cancer, if there is any evidence
             of other malignancy being present within the last five years; patients are also
             ineligible if their previous cancer treatment contraindicates this protocol therapy

          -  Patients for whom radiotherapy is planned after or during chemotherapy prior to
             progression of cancer

          -  Patients with known hypersensitivity to Escherichia (E.) coli-derived drug
             preparations (pegfilgrastim and filgrastim [G-CSF])

          -  Patients with a known hypersensitivity to mesna or other thiol compounds

          -  For enrollment prior to 10/21/2013, patients who are not biopsy proven to have
             carcinosarcoma of the uterus, fallopian tube, peritoneum or ovary; for enrollment
             after 10/21/2013, patients who are not biopsy proven to have carcinosarcoma of the
             uterus