Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma, including any of the following epithelial cell types:

  • Serous adenocarcinoma
  • Endometrioid adenocarcinoma
  • Mucinous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Mixed epithelial carcinoma
  • Transitional cell carcinoma
  • Malignant Brenner tumor
  • Adenocarcinoma not otherwise specified

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam or ≥ 20 mm by chest x-ray

  • Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

• Must have ≥ 1 target lesion to assess response as defined by RECIST 1.1 criteria

  • Tumors within a previously irradiated field will be designated as "non-target" lesions unless there is documented disease progression or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy

• Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of the primary disease

  • Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, non-cytotoxic therapy, or extended therapy administered after surgical or non-surgical assessment

  • No additional cytotoxic chemotherapy for management of recurrent or persistent disease, including re-treatment with initial chemotherapy regimens

    • One additional non-cytotoxic regimen for management of recurrent or persistent disease allowed
• Must be considered platinum-resistant or refractory according to standard GOG criteria (i.e., treatment-free interval of < 6 months after completion of platinum-based therapy OR progressed during platinum-based therapy)
• Not eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• ANC ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 3.0 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• LDH levels ≤ 0.8 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No neuropathy (sensory and motor) > grade 1 by CTCAE criteria
• No active infection requiring antibiotics, except uncomplicated urinary tract infection
• No other invasive malignancies within the past 5 years, except nonmelanoma skin cancer or other specific malignancies

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior surgery, radiotherapy, or chemotherapy
• At least 1 week since prior hormonal therapy directed at the malignant tumor
• At least 3 weeks since prior biological therapy, immunotherapy, or other therapy directed at the malignant tumor
• No prior radiotherapy to > 25% of marrow-bearing areas

• No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

  • Prior radiotherapy for localized cancer of the breast, head and neck, or skin allowed provided it was completed > 3 years ago and the patient remains free of recurrent or metastatic disease

• No prior chemotherapy for any abdominal or pelvic tumor, except for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

  • Prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed > 3 years ago and the patient remains free of recurrent or metastatic disease
• No prior elesclomol sodium
• No prior second-line cytotoxic chemotherapy
• No prior cancer treatment that would contraindicate study therapy