Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube Mucinous Adenocarcinoma; Fallopian Tube Serous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Fallopian Tube Undifferentiated Carcinoma; Ovarian Brenner Tumor; Ovarian Clear Cell Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Adenocarcinoma; Ovarian Transitional Cell Tumor; Ovarian Undifferentiated Carcinoma; Primary Peritoneal Serous Adenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Adenocarcinoma; Carcinoma, Transitional Cell; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Adenocarcinoma, Clear Cell; Adenocarcinoma, Mucinous; Cystadenocarcinoma; Brenner Tumor; Recurrence
Intervention: Elesclomol Sodium; Paclitaxel
Intervention description: Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well elesclomol sodium and paclitaxel work in treating
      patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer
      that has returned after a period of improvement (recurrent) or is persistent. Drugs used in
      chemotherapy, such as elesclomol sodium and paclitaxel, 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. Elesclomol sodium may also help paclitaxel work better by
      making tumor cells more sensitive to the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube or
             primary peritoneal carcinoma; histologic documentation of the original primary tumor
             is required via the pathology report

               -  Patients with the following histologic epithelial cell types are eligible: serous
                  adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
                  undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial
                  carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or
                  adenocarcinoma not otherwise specified (N.O.S.)

          -  All patients must have measurable disease as defined by Response Evaluation Criteria
             in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion
             that can be accurately measured in at least one dimension (longest diameter to be
             recorded); each lesion must be >= 10 mm when measured by computed tomography (CT),
             magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm
             when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured
             by CT or MRI

          -  Patients must have at least one "target lesion" to be used to assess response on this
             protocol as defined by RECIST 1.1; 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

          -  Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)
             protocol, if one exists; in general, this would refer to any active GOG phase III
             protocol for the same patient population

          -  Patients must have a GOG performance status of 0, 1, or 2

          -  Patients must have baseline lactate dehydrogenase (LDH) levels =< 0.8 x upper limit of
             normal (ULN)

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy

               -  Patients should be free of active infection requiring antibiotics (with the
                  exception of uncomplicated urinary tract infection [UTI])

               -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                  least one week prior to registration

               -  Any other prior therapy directed at the malignant tumor, including biological and
                  immunologic agents, must be discontinued at least three weeks prior to
                  registration

          -  Prior therapy

               -  Patients must have had one prior platinum-based chemotherapeutic regimen for
                  management of primary disease containing carboplatin, cisplatin, or another
                  organoplatinum compound; this initial treatment may have included intraperitoneal
                  therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended
                  therapy administered after surgical or non-surgical assessment

               -  Patients must have NOT received any additional cytotoxic chemotherapy for
                  management of recurrent or persistent disease, including retreatment with initial
                  chemotherapy regimens; (Note: optimal evaluation of the safety and efficacy of
                  new chemotherapy regimens is best performed in patients with minimal prior
                  therapy; non-investigational therapy, such as retreatment with platinum and/or
                  paclitaxel, is non-curative in the setting of recurrent disease, and can
                  generally be safely administered to patients following participation in a phase
                  II trial)

               -  Patients are allowed to receive, but are not required to receive, one additional
                  non-cytotoxic regimen for management of recurrent or persistent disease according
                  to the following definition:

               -  Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to)
                  hormones, monoclonal antibodies, cytokines, and small-molecule inhibitors of
                  signal transduction

               -  Patients must be considered platinum resistant or refractory according to
                  standard GOG criteria, i.e., have had a treatment-free interval following
                  platinum of less than 6 months, or have progressed during platinum-based therapy

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

          -  Platelets greater than or equal to 100,000/mcl

          -  Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)

          -  Bilirubin less than or equal to 1.5 x ULN

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less
             than or equal to 3 x ULN

          -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  Neurologic function: neuropathy (sensory and motor) less than or equal to Common
             Terminology Criteria for Adverse Events (CTCAE) grade 1

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Patients must meet pre-entry requirements

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             study entry and be practicing an effective form of contraception

          -  Cautions and prohibited medications/treatments

               -  Since elesclomol is a substrate for cytochrome P450 family 2, subfamily C,
                  polypeptide 9 (CYP2C9), cytochrome P450 family 2, subfamily D, polypeptide 6
                  (CYP2D6), cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19), and
                  cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) and an inducer of
                  CYP3A4, cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2), cytochrome
                  P450 family 2, subfamily A, polypeptide 6 (CYP2A6), and cytochrome P450 family 2,
                  subfamily E, polypeptide 1 (CY2E1), it is recommended that the following be used
                  with caution: sensitive substrates of CYP3A4, CYP1A2, and CY2E1, and strong
                  inhibitors and inducers of CYP2C9, CYP2D6, CYP2C19, and CYP3A4

        Exclusion Criteria:

          -  Patients who have had prior therapy with elesclomol or prior second-line cytotoxic
             chemotherapy

          -  Patients who have received radiation to more than 25% of marrow-bearing areas

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer and other specific malignancies are excluded if there is any
             evidence of other malignancy being present within the last three years; patients are
             also excluded if their previous cancer treatment contraindicates this protocol therapy

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary
             peritoneal cancer are excluded; prior radiation for localized cancer of the breast,
             head and neck, or skin is permitted, provided that it was completed more than three
             years prior to registration, and the patient remains free of recurrent or metastatic
             disease

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
             THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are
             excluded; patients may have received prior adjuvant chemotherapy for localized breast
             cancer, provided that it was completed more than three years prior to registration,
             and that the patient remains free of recurrent or metastatic disease

          -  Patients who are pregnant or breastfeeding