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Status:

COMPLETED

Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Collaborating Sponsors:

Radiation Therapy Oncology Group

Conditions:

Cervical Adenocarcinoma

Cervical Adenosquamous Carcinoma

Eligibility:

FEMALE

Phase:

PHASE2

Brief 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. Monoclo...

Detailed Description

PRIMARY OBJECTIVES: I. Determine treatment-related serious adverse-event rates and adverse-event rates within the first 90 days from treatment start in patients with previously untreated locally adva...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 11 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 15 2016

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00369122

    Start Date

    August 11 2006

    End Date

    December 15 2016

    Last Update

    March 20 2018

    Active Locations (106)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 27 (106 locations)

    1

    Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, United States, 91505

    2

    University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States, 95817

    3

    Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, United States, 80907

    4

    University of Colorado

    Denver, Colorado, United States, 80217-3364