Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Inclusion Criteria:

• Histologically confirmed diagnosis of 1 of the following:

  • Ovarian epithelial cancer
  • Fallopian tube cancer
  • Primary peritoneal carcinoma
• Recurrent or persistent disease

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

  • Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, or extended therapy administered after a surgical or nonsurgical assessment
  • Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel

• Platinum-resistant or refractory disease, defined by 1 of the following:

  • Treatment-free interval of \< 6 months after completion of platinum-based therapy
  • Persistent disease at completion of primary platinum-based therapy
  • Progressive disease during platinum-based therapy

• Paclitaxel-resistant disease, defined as having had a treatment-free interval \< 6 months or shown disease progression during paclitaxel-based therapy

  • Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

• Must have ≥ 1 target lesion that can be used to assess response

  • Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or biopsy confirms persistence ≥ 90 days after completion of radiotherapy
• Not a candidate for a higher priority GOG protocol
• GOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin normal
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• No active infection requiring antibiotics
• No sensory or motor neuropathy > grade 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PT INR ≤ 1.5 or in-range INR 2-3 (if patient is on a stable dose of therapeutic warfarin)
• PTT \< 1.2 times control
• No concurrent serious medical or psychiatric illness, including serious active infection
• No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
• No uncompensated congestive heart failure or symptomatic coronary artery disease
• No myocardial infarction within the past 6 months
• No active bleeding
• No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
• No history of allergic reactions attributed to chemical or biological composition to paclitaxel or other study agents
• No concurrent amifostine or other protective reagents
• Recovered from prior surgery, radiotherapy, or chemotherapy
• No prior paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®)
• No prior cancer treatment that would preclude study therapy
• No additional prior cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens
• One additional prior noncytotoxic regimen (i.e., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for management of recurrent or persistent disease allowed

• At least 1 week since prior hormonal therapy directed at the malignant tumor

  • Concurrent hormone replacement therapy allowed
• At least 3 weeks since other prior therapy directed at the malignant tumor, including biologic therapy, immunologic agents, or radiotherapy

• More than 5 years since prior chemotherapy for any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer

  • Prior adjuvant chemotherapy for localized breast cancer allowed provided it was completed > 3 years ago and patient remains free of recurrent or metastatic disease

• More than 5 years since prior radiotherapy to any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer

  • Prior radiotherapy for localized breast cancer, cancer of the head and neck, or skin cancer allowed provided it was completed > 3 years ago and patient remains free of recurrent or metastatic disease
• No prior radiotherapy to > 25% of marrow-bearing areas