Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy
Condition: Brenner Tumor; Fallopian Tube Cancer; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer
MeSH terms: Adenocarcinoma; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Endometrioid; Cystadenocarcinoma; Cystadenocarcinoma, Serous; Carcinoma; Cystadenocarcinoma, Mucinous; Brenner Tumor
Intervention: sargramostim; paclitaxel albumin-stabilized nanoparticle formulation; laboratory biomarker analysis; immunologic technique
Intervention description: Given SC; Given IV; Correlative studies; Correlative studies
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the
      immune system in different ways and stop tumor cells from growing and may also increase the
      number of immune cells found in bone marrow or peripheral blood and help the immune system
      recover from the side effects of chemotherapy. 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. Giving GM-CSF
      together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective
      treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

      PURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel
      albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian
      cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to previous
      chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically proven epithelial ovarian, fallopian tube or primary
             peritoneal malignancies, excluding tumors of low malignant potential (borderline)

          -  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

          -  Patients must have either primary platinum refractory or resistant carcinoma or
             secondary platinum resistant disease:

               1. Primary platinum refractory disease is defined as progression of disease on
                  initial platinum-based chemotherapy or persistent disease at the conclusion of
                  the initial platinum-based chemotherapy course associated with the primary
                  debulking surgery.

               2. Primary platinum resistant disease is defined as recurrence of carcinoma within 6
                  months (+ 14 days) of completion of initial platinum-based chemotherapy
                  associated with the primary debulking surgery. (The 14 day window is to allow
                  study entry for those patients where evidence clearly suggests that had an
                  assessment been made early the patient would have met the 6 month time line. This
                  will be determined by the study principal investigator [P.I.])

               3. Secondary platinum resistant disease is defined as meeting any one of the listed
                  criteria during or following a subsequent platinum containing regimen.

          -  Patients must have an elevated serum cancer antigen (CA)125 on two occasions greater
             than 7 days apart

          -  Absolute neutrophil count >= 1500/uL

          -  Platelets >= 100,000/uL

          -  Creatinine =< 2.0 mg/dL

          -  Total bilirubin =< 1.5 mg/dL (unless history of Gilbert's disease)

          -  Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x upper limit of normal (ULN) or
             < 5 x ULN with documented report of hepatic metastases

          -  Patients must have recovered from effects of recent surgery, radiotherapy, or
             chemotherapy; at least three weeks must have elapsed since prior chemotherapy or
             radiation therapy

        Exclusion Criteria:

          -  Patient has an allergic history to paclitaxel or GM-CSF, not manageable by
             pre-medication and/or slow drug infusion

          -  Patient has poorly controlled arrhythmias or unstable coronary artery disease or has
             had a myocardial infarction within the last six months

          -  Patient with active pulmonary edema or pleural effusion

          -  Active infection requiring IV antibiotics

          -  Patient currently requires lithium, (due to drug interaction with GM-CSF [Leukine])

          -  Patient currently presents with a neurotoxicity > Grade 1

          -  Women of childbearing potential

          -  Patients with a history of other invasive malignancies, within the previous 5 years
             are excluded, with the exception of non-melanoma skin cancer