Trial Search Results

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gynecologic Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Carboplatin
  • Drug: Ifosfamide
  • Drug: Paclitaxel
  • Other: Quality-of-Life Assessment

Phase:

Phase 3

Eligibility


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 na?ve 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting