Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma
MeSH terms: Carcinoma; Recurrence
Intervention: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
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: 51.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized
      nanoparticle formulation works in treating patients with recurrent or persistent ovarian
      epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in
      chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing.
    

Eligibility criteria:

        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