Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: sorafenib tosylate; immunoenzyme technique; immunohistochemistry staining method; laboratory biomarker analysis; pharmacological study
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer; stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Summary:

      RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with
      ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in at least the second
      remission.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or
             peritoneum

               -  Any stage and grade at diagnosis

          -  Must have received initial cytoreductive surgery and chemotherapy with ≥ 1
             platinum-based chemotherapy regimen

               -  Persistent or recurrent disease after initial therapy

          -  In complete clinical remission after chemotherapy for recurrent disease, meeting all
             of the following criteria:

               -  CA125 ≤ 35 units/L

               -  Normal physical examination

               -  No definite evidence of disease by CT scan of the abdomen and pelvis

                    -  Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm are not considered
                       definite evidence of disease

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  Karnofsky performance status 70-100%

          -  Life expectancy > 3 months

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9.0 g/dL

          -  INR < 1.5 OR PT/PTT within normal limits

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Urinalysis negative for protein

               -  If urinalysis shows 1+ protein by dipstick or protein ≥ 30-100 mg/dL by
                  semi-quantitative assay, a 24-hour urine collection is required

                    -  Eligible patients must have a total urinary protein ≤ 500 mg AND measured
                       creatinine clearance ≥ 50 mL/min from a 24-hour urine collection

          -  Bilirubin ≤ 1.5 times ULN

          -  AST and ALT ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Stable blood pressure (BP) measurement required on 3 separate days prior to the start
             of treatment

          -  No peripheral neuropathy > grade 1

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion criteria:

          -  Other invasive malignancies within the past 5 years, except nonmelanoma skin cancer

          -  Uncontrolled concurrent illness or medical condition including, but not limited to,
             any of the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Uncontrolled diabetes

          -  Psychiatric illness or social situation that would preclude study compliance

          -  Uncontrolled hypertension defined as a persistent BP > 150/100 mm Hg (or a persistent
             BP > 180/90 mm Hg if the patient has a history of isolated systolic hypertension)
             despite ≥ 2 attempts at antihypertensive medication dosage adjustment ≥ 2 weeks apart

          -  Thrombolic or embolic events such as cerebrovascular accident, including transient
             ischemic attack, within the past 6 months

          -  Pulmonary hemorrhage or bleeding event ≥ grade 2 within 4 weeks of the first dose of
             study drug

          -  Other hemorrhage or bleeding event ≥ grade 3 within 4 weeks of the first dose of study
             drug

          -  Serious nonhealing wound, ulcer, or bone fracture

          -  Evidence or history of bleeding diathesis or coagulopathy

          -  Inability to take oral medications or gastrointestinal condition that compromises
             absorption

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to sorafenib tosylate

        PRIOR CONCURRENT THERAPY:

        Inclusion criteria:

          -  See Disease Characteristics

          -  No prior sorafenib tosylate or other inhibitors of MAPK signaling intermediates or
             angiogenesis inhibitors

          -  No prior cancer treatment that would contraindicate protocol therapy

          -  More than 4 weeks since prior radiotherapy

          -  More than 3 weeks since prior chemotherapy, biological therapy, or immunotherapy

          -  More than 1 week since prior hormonal therapy for cancer treatment

        Exclusion criteria:

          -  Major surgery (i.e., laparotomy) within the past 4 weeks or minor surgery within the
             past 2 weeks

               -  Placement of a vascular access device is not considered minor surgery

          -  Concurrent combination antiretroviral therapy for HIV-positive patients

          -  Concurrent St. John wort, rifampin, or enzyme-inducing anticonvulsants (e.g.,
             carbamazepine, phenytoin, or phenobarbital)