Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer
Condition: Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Stage IB Cervical Cancer AJCC v6 and v7; Stage IIA Cervical Cancer AJCC v7; Stage IIB Cervical Cancer AJCC v6 and v7; Stage III Cervical Cancer AJCC v6 and v7
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Uterine Cervical Neoplasms; Carcinoma, Adenosquamous
Intervention: Bevacizumab; Cisplatin; External Beam Radiation Therapy; Internal Radiation Therapy
Intervention description: Given IV; Given IV; Undergo EBRT; Undergo brachytherapy
Intervention MeSH terms: Bevacizumab; Antineoplastic Agents, Immunological; Cisplatin; Endothelial Growth Factors; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving bevacizumab together with radiation therapy
      and cisplatin works in treating patients with previously untreated locally advanced cervical
      cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.
      Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
      kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of
      cervical cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy
      x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving bevacizumab together with radiation therapy and cisplatin may kill more
      tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed squamous cell, adenocarcinoma, or adenosquamous cell
             carcinoma of the uterine cervix, meeting 1 of the following stage criteria:

               -  Stage IIB-IIIB lymph nodes

               -  Stage IB-IIA disease with biopsy-proven pelvic node metastases and/or tumor size
                  >= 5 cm

          -  No positive para-aortic lymph nodes

          -  Zubrod performance status 0-2

          -  WBC >= 3,000/mm^3

          -  Absolute granulocyte count >= 1,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  INR < 1.5

          -  Total bilirubin =< 1.5 mg/dL

          -  Serum creatinine =< 1.5 mg/dL

          -  AST and ALT =< 2.5 times upper limit of normal (ULN)

          -  Serum calcium =< 1.3 times ULN

          -  Hemoglobin >= 10 g/dL (transfusion allowed)

          -  Urine protein:creatinine ratio ? 0.5 OR urine protein < 1,000 mg by 24-hour urine
             collection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  None of the following illnesses or conditions:

               -  Medical illness preventing the use of full-dose chemotherapy

               -  Evidence of bleeding diathesis or coagulopathy

               -  Prior medical or psychiatric illness that would prevent informed consent or limit
                  survival to < 6 months

               -  History of aneurysms, cerebrovascular accident, or arteriovenous malformations

               -  Active gastrointestinal (GI) ulcers, GI bleeding, or active inflammatory bowel
                  disease

               -  Serious, nonhealing wound, ulcer, or current healing fracture

               -  History of any type of fistula or GI perforation

               -  Intra-abdominal abscess within the past 6 months

          -  No prior invasive malignancy (except nonmelanomatous skin cancer) unless disease free
             for >= 3 years

          -  No significant traumatic injury within the past 28 days

          -  No clinically significant cardiovascular disease, such as the following:

               -  Uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication)

               -  Myocardial infarction within the past 12 months

               -  Unstable angina within the past 12 months

               -  New York Heart Association class II-IV congestive heart failure

               -  Unstable symptomatic arrhythmia requiring medication (i.e., chronic atrial
                  arrhythmia, atrial fibrillation, or paroxysmal supraventricular tachycardia)

               -  Arterial thromboembolic events, including transient ischemic attack or clinically
                  significant peripheral artery disease, within the past 6 months

          -  Arterial thromboembolic events, including transient ischemic attack or clinically
             significant peripheral artery disease, within the past 6 months

          -  No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
             human antibodies

          -  No known HIV

          -  No prior organ transplant

          -  No prior surgery for carcinoma of the cervix other than biopsy

          -  No prior surgical debulking of pelvic or para-aortic nodes

          -  No prior pelvic radiotherapy, including transvaginal irradiation to control bleeding

          -  No prior systemic chemotherapy

          -  No major surgical procedure or open biopsy within the past 28 days or anticipation of
             need for major surgical procedure during the course of the study

          -  No fine needle aspirations or core biopsies within the past 7 days

          -  No concurrent major surgical procedure

          -  No concurrent epoetin alfa or Hypericum perforatum (St. John's wort)

          -  No concurrent intensity-modulated radiotherapy

          -  No concurrent transvaginal irradiation to control bleeding