Clinical trial NCT00600210 (phase 2, status: withdrawn)
Conditions: cervical cancer
ICD codes: M50.20, M50.21, M50.30, M50.31, M50.80, M50.81, M50.90
Drugs: bevacizumab, carboplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    low patient accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have IB2 and IIA tumors greater than 4 cm in diameter, IIB, IIIB without
             hydronephrosis or non-functioning kidney, and IVA without invasion to the bladder or
             rectum, primary, previously untreated, and histologically confirmed invasive squamous
             cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.

          -  Negative, non-suspicious para-aortic nodes determined by CT lymphangiogram, MRI or
             lymphadenectomy.

          -  Adequate bone marrow function: ANC greater ≥ 1,500/mm3, platelets ≥ 100,000/mm3.

          -  Adequate renal function: serum creatinine ≤ 1.5 mg/100 mL.

          -  Adequate hepatic function: bilirubin less than or equal to 1.5 x upper limit of normal
             (ULN) and SGOT and alkaline phosphatase less than or equal to 3 x ULN.

          -  Zubrod Performance Status of 0 or 1

          -  Patients of childbearing potential must have a negative serum pregnancy test within14
             days of enrolling in this study and use an effective form of contraception during the
             study period.

          -  Patients who are medically suitable for treatment with radical intent using concurrent
             chemotherapy and pelvic radiation.

        Exclusion Criteria:

          -  Patients with Stage IA, IB1, IB2 and IIa tumors less than 4 cm in diameter, IIIA or
             IVB disease.

          -  Patients who have known metastases to para-aortic or scalene nodes or metastases to
             other organs outside the radiation field at the time of the original clinical and
             surgical staging.

          -  Extensive tumor preventing intracavitary irradiation.

          -  Distal vaginal involvement or any disease such that an interstitial implant might be
             necessary

          -  Previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of
             any kind for this malignancy.

          -  Patients who might require an emergency surgical procedure to relieve hydronephrosis,
             or who are at risk of perforating the bladder and might require surgery.

          -  Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal
             transplantation, that would require modification of radiation fields

          -  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
             bevacizumab cancer study.

          -  Septicemia or severe infection

          -  Patients who have circumstances that will not permit completion of this study or the
             required follow-up.

          -  Patients who are pregnant at the time of diagnosis and do not wish pregnancy
             termination prior to initiation of treatment.

          -  Other concomitant malignancies, with the exception of nonmelanoma skin cancer, who had
             (or have) any evidence of other cancer present within the last 5 years.

          -  Bevacizumab-Specific Exclusions

          -  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

          -  Known CNS disease

          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

          -  Symptomatic peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study enrollment or anticipation of need for major surgical procedure during
             the course of the study

          -  Core biopsy or other minor surgical procedure, excluding placement of a vascular
             access device, within 7 days prior to study enrollment

          -  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 bevacizumab

          -  Pregnant (positive pregnancy test) or lactating. Use of effective means of
             contraception (men and women) in subjects of child-bearing potential

          -  Any history of stroke or transient ischemic attack at any time

          -  History of myocardial infarction or unstable angina within 6 months of study
             enrollment

          -  Carboplatin-Specific Exclusions

          -  History of severe allergic reactions to cisplatin or other platinum-containing
             compounds.

          -  Patients with severe bone marrow depression or significant bleeding.