A Phase II Evaluation of Abraxane Plus Bevacizumab for the Treatment of Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- Patients must have histologically or cytologically confirmed recurrent epithelial
ovarian, fallopian tube or primary peritoneal carcinoma. Histologic documentation of
the original primary tumor is required via the pathology report.
- All patients must have measurable disease. Measurable disease is defined as at least
one lesion that can be accurately measured in at least one dimension (longest
dimension to be recorded). Each lesion must be >20mm when measured by conventional
techniques including CT, and MRI, or >10 mm when measured by spiral CT.
- Patients must have at least one "target lesion" to be used to assess response as
defined by RECIST. Tumors within a previously irradiated field will be designated as
"non-target" lesions unless progression is documented or a biopsy is obtained to
confirm persistence at least 90 days following completion of radiation therapy.
- Patients must have had one prior platinum-based chemotherapeutic regimen for
management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound. This initial treatment may have included intraperitoneal
therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy
administered after surgical or non-surgical assessment.
- Patients are required to receive at least one additional cytotoxic regimen for
management of recurrent or persistent disease. Patients are allowed to receive, but
are not required to receive, biologic (non-cytotoxic) therapy either alone or as part
of the cytotoxic regimens for management of recurrent or persistent disease.
- Age >18 years. Women all races and ethnic groups will be included.
- Patients with an ECOG performance status < 2. ( see APPENDIX A)
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count >1,500/uL
- platelets >100,000/uL
- hemoglobin >9 g/dL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- Alkaline Phosphatase within normal institutional limits
- creatinine <1.5 X institutional upper limit of normal
- Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v4.0
grade 2. (see APPENDIX B)
- Ability to understand and the willingness to sign a written informed consent
- Patients who have had chemotherapy or radiotherapy within 28 days prior to entering
the study or whose adverse events due to agents administered more than 28 days
earlier continue to be grade 3 or greater.
- Patients may not have received any other investigational agents within the past 28
- Any hormonal therapy or immunotherapy directed at the malignant tumor must be
discontinued at least one week prior to enrollment. Continuation of hormone
replacement therapy is permitted. Continuation of other established medical
treatments for a known medical condition is permitted.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Abraxane or Bevacizumab.
- Patients who have had prior therapy with Abraxane.
- Patients who have received radiation to more than 25% of marrow-bearing areas. (see
- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years.
- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary
peritoneal cancer within the last five years are excluded. Prior radiation for
localized cancer of the breast, head and neck, or skin is permitted, provided that it
was completed more than five years prior to registration, and the patient remains
free of recurrent or metastatic disease.
- Patients who have known active liver disease or hepatitis.
- Patients with active bleeding or pathologic conditions that carry high risk of
bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
- Patients with history or evidence upon physical examination of CNS disease, including
primary brain tumor, seizures not controlled with standard medical therapy, any brain
metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic
attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of
treatment on this study.
- Patients with clinically significant cardiovascular disease, including:
uncontrolled hypertension, myocardial infarction, unstable angina within 6 months of
enrollment, NYHA Grade II or greater heart failure, serious cardiac arrhythmia requiring
medication, grade II or greater peripheral vascular disease.
- Patients with clinically significant proteinuria. Patients with a urine protein of
1+ on dipstick should undergo a 24-hour urine collection, which must demonstrate <
100 mg protein/24 hr to allow participation in the study.
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human or humanized antibodies.
- Patients who have a major surgical procedure, open biopsy, or significant traumatic
injury within 28 days prior to enrollment on the study, or anticipation of need for
major surgical procedure during the course of the study.
- Patients who have received commercial bevacizumab within 28 days prior to enrollment
on the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection(with the exception of uncomplicated UTI), chronic non- healing wound, bone
fracture, or psychiatric illness/social situations that would limit compliance with
- Pregnant or lactating women are excluded from this study because of possible risk to
the fetus or infant.
- Known HIV-positive patients are excluded from the study because of possible risk of
lethal infection when treated with marrow suppressive therapy.
- Safety data regarding Abraxane use in patients with ascites is not available;
therefore patients with symptomatic ascites will be excluded from participation in
the study. Patients may have asymptomatic ascites.