Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers
Condition: Cervical Cancer; Endometrial Cancer; Ovarian Cancer; Vaginal Cancer; Carcinoma of the Vulva
MeSH terms: Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms
Intervention: Avastin
Intervention description: Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent Endometrial cancer; Recurrent Cervical cancer; Recurrent Ovarian cancer; Recurrent Vaginal cancer; Recurrent Vulvar cancer; Vaginal recurrence; Brachytherapy; Radiation Treatment; External Beam Radiation; Avastin; Bevacizumab

Summary:

      This research study is evaluating a drug called avastin in combination with standard
      radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological
      cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients (age > 18 years) will have locally recurrent gynecological cancer with a
             component of disease that will fit within a standard RT portal at the time of
             presentation

          -  ECOG performance status score 0-1

          -  All patients will have had a prior hysterectomy

          -  Histological confirmation of recurrent gynecological cancer, including adenocarcinoma,
             papillary serous carcinoma, clear cell carcinoma, or carcinosarcoma

          -  Age > 18 years

          -  Radiologic work-up computer tomography of the chest and abdomen, and computer
             tomography or MR of the pelvis confirming pelvis-confined recurrence

          -  Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL

          -  Adequate hepatic function as evidenced by:

        Serum total bilirubin < 1.5 mg/dL SGOT/SGPT < 3X the ULN for the reference lab

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients with a prior history of full course external beam radiation therapy to the
             pelvis (patients with prior vaginal brachytherapy may be included)

          -  Inability to comply with study and/or follow-up procedures

          -  Life expectancy of less than 12 weeks

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored avastin
             cancer study

          -  Known CNS disease (including history of encephalitis, multiple sclerosis or seizure
             disorder), except for treated brain metastasis

          -  Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or
             diastolic blood pressure > 100 mmHg on antihypertensive medications)

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure

          -  History of myocardial infarction or unstable angina within 6 months prior to study
             enrollment

          -  History of stroke or transient ischemic attack within 6 months prior to study
             enrollment

          -  Known CNS disease (including history of encephalitis, multiple sclerosis or seizure
             disorder)

          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

          -  Symptomatic peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Any surgical procedure requiring an incision, open biopsy, or significant traumatic
             injury within 28 days prior to study enrollment or anticipation of need for any
             surgical procedure requiring an incision during the course of the study (excluding
             vascular access device placement or procedures that do not require an incision)

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to study enrollment

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC)
             ratio ≥ 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered
             to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour
             urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).

          -  Known hypersensitivity to any component of avastin

          -  Any other medical condition, including mental illness or substance abuse, deemed by
             the Investigator to be likely to interfere with a patient's ability to give informed
             consent or cooperate and participate in the study or to interfere with the
             investigator's ability to interpret the results