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Active Clinical Trials: Gynecology- Cervical

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ProtocolTitle
GOG-0240A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865, IND #7921) Versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied Bevacizumab, in Stage IVB, Recurrent or (1702)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Histologically confirmed carcinoma of the cervix, including any of the following subtypes:

    Squamous cell carcinoma
    Adenosquamous cell carcinoma
    Adenocarcinoma
    Primary stage IVB, recurrent, or persistent disease not amenable to curative treatment with surgery and/or radiotherapy
    Measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm by conventional techniques or = 10 mm by spiral CT scan

    Biopsy confirmation required if target lesion(s) measures < 30 mm or if the treating physician determines it is clinically indicated
    Has = 1 "target lesion" that can be used to assess response

    Tumors within a previously irradiated field are designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence = 90 days following completion of radiotherapy
    No history or evidence of CNS disease, including primary brain tumor, brain metastases, or craniospinal metastases
    PATIENT CHARACTERISTICS:

    GOG performance status 0-1
    ANC = 1,500/mm³
    Platelet count = 100,000/mm³
    Bilirubin = 1.5 times normal
    SGOT = 2.5 times normal
    Alkaline phosphatase = 2.5 times normal
    PT/INR = 1.5 (or in-range INR, if patient is on a stable dose of therapeutic warfarin for management of venous thrombosis, including pulmonary thromboembolus)
    PTT < 1.2 times upper limit of normal
    Serum creatinine normal OR creatinine clearance = 60 mL/min
    Urine protein:creatinine ratio 1.0 mg/dL
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception during and for = 6 months after completion of study treatment
    No active infection requiring antibiotics
    No significant traumatic injury within the past 28 days
    No serious non-healing wound, ulcer, or bone fracture

    Patients with granulating incisions healing by secondary intention are eligible provided there is no evidence of fascial dehiscence or infection AND the wound is examined weekly
    No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 3-6 months

    Patients must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation
    No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition
    No active bleeding or pathologic condition that carries a high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels)
    No seizures not controlled with standard medical therapy
    No cerebrovascular accident (i.e., stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
    No clinically significant cardiovascular disease, including any of the following:

    Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg
    Myocardial infarction or unstable angina within the past 6 months
    NYHA class II-IV congestive heart failure
    Serious cardiac arrhythmia requiring medication

    Atrial fibrillation allowed provided it is asymptomatic and ventricular rate is controlled
    Significant peripheral vascular disease (i.e., = grade 2 peripheral vascular disease, as defined by NCI CTCAE v3.0 criteria)
    No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
    No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
    No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer
    No other medical history or condition that, in the opinion of the investigator, would preclude study participation
    No peripheral neuropathy = grade 2
    PRIOR CONCURRENT THERAPY:

    Recovered from all prior therapy
    No prior anti-cancer therapy that would preclude study therapy
    No prior anti-VEGF drugs, including bevacizumab
    No prior chemotherapy unless given concurrently with radiotherapy

    Prior paclitaxel and/or topotecan with radiotherapy not allowed
    At least 6 weeks since

  • Consent Forms: 0240 NCI Consent
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