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A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bevacizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Recurrent ovarian cancer, Refractory ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent Female, age >=18 years Advanced (Stage III or IV), histologically documented epithelial ovarian cancer or primary peritoneal cancer Platinum-resistant disease Platinum-resistant disease that subsequently progressed either during treatment with Doxil(R) or Hycamtin(R) therapy or within 3 months of discontinuing treatment with Doxil(R) or Hycamtin(R) therapy Received no more than three treatment regimens Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded) according to RECIST (with the exception that spiral CT scans of up to 8-mm slice thickness will be accepted) Recovered from prior cancer therapy (XRT, surgery, chemotherapy) ECOG performance status 0 or 1 Life expectancy >12 weeks Use of an effective means of contraception (for women of childbearing potential) Exclusion Criteria: Four or more treatment regimens Prior therapy with bevacizumab or other VEGF pathway-targeted therapy Current, recent (within 4 weeks of the first infusion of bevacizumab), or planned treatment with an experimental drug other than this Genentech-sponsored bevacizumab cancer study Screening clinical laboratory values: Granulocyte count <1500/uL; Platelet count <75,000/uL; Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp(R)] is permitted); Serum bilirubin >2.0 x upper limits of normal (ULN); Alkaline phosphatase, AST, and ALT >2.5 x ULN (AST, ALT >5 x ULN for subjects with liver metastasis); Serum creatinine >2.0; International normalized ratio (INR) >1.5 and activated partial thromboplastin time (aPTT) >1.5 x ULN (except for subjects receiving anticoagulation therapy); Urine protein/creatinine ratio >1.0 at screening Blood pressure >150/100 mmHg Unstable angina New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix B). Women who have received prior Doxil(R) therapy and have an ejection fraction <50% will be excluded from the study. History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab infusion) History of stroke or transient ischemic attack within 6 months prior to Day 0 Clinically significant peripheral vascular disease Evidence of bleeding diathesis or coagulopathy Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the course of the study Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0 History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 Serious, non-healing wound, ulcer, or bone fracture Presence of central nervous system or brain metastases History of other malignancies within 5 years of Day 0, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer Pregnant (positive pregnancy test) or lactating Inability to comply with study and follow-up procedures Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 17, 2004
    Last Updated
    May 15, 2017
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00097019
    Brief Title
    A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed
    Official Title
    A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects With Platinum-Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for Whom Subsequent Doxil or Topotecan Therapy Has Failed
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2005 (Actual)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open-label, single-arm, two-stage, multicenter Phase II study evaluating the efficacy and safety of bevacizumab in women with platinum resistant, advanced (Stage III or IV) EOC (epithelial ovarian cancer) or PPC (primary peritoneal cancer) that subsequently progressed either during treatment with Doxil or Hycamtin therapy or within 3 months of discontinuing treatment with Doxil or Hycamtin therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer
    Keywords
    Recurrent ovarian cancer, Refractory ovarian cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    53 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    bevacizumab

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Female, age >=18 years Advanced (Stage III or IV), histologically documented epithelial ovarian cancer or primary peritoneal cancer Platinum-resistant disease Platinum-resistant disease that subsequently progressed either during treatment with Doxil(R) or Hycamtin(R) therapy or within 3 months of discontinuing treatment with Doxil(R) or Hycamtin(R) therapy Received no more than three treatment regimens Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded) according to RECIST (with the exception that spiral CT scans of up to 8-mm slice thickness will be accepted) Recovered from prior cancer therapy (XRT, surgery, chemotherapy) ECOG performance status 0 or 1 Life expectancy >12 weeks Use of an effective means of contraception (for women of childbearing potential) Exclusion Criteria: Four or more treatment regimens Prior therapy with bevacizumab or other VEGF pathway-targeted therapy Current, recent (within 4 weeks of the first infusion of bevacizumab), or planned treatment with an experimental drug other than this Genentech-sponsored bevacizumab cancer study Screening clinical laboratory values: Granulocyte count <1500/uL; Platelet count <75,000/uL; Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp(R)] is permitted); Serum bilirubin >2.0 x upper limits of normal (ULN); Alkaline phosphatase, AST, and ALT >2.5 x ULN (AST, ALT >5 x ULN for subjects with liver metastasis); Serum creatinine >2.0; International normalized ratio (INR) >1.5 and activated partial thromboplastin time (aPTT) >1.5 x ULN (except for subjects receiving anticoagulation therapy); Urine protein/creatinine ratio >1.0 at screening Blood pressure >150/100 mmHg Unstable angina New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix B). Women who have received prior Doxil(R) therapy and have an ejection fraction <50% will be excluded from the study. History of myocardial infarction within 6 months prior to Day 0 (the day of the first bevacizumab infusion) History of stroke or transient ischemic attack within 6 months prior to Day 0 Clinically significant peripheral vascular disease Evidence of bleeding diathesis or coagulopathy Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major elective surgical procedure during the course of the study Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0 History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 Serious, non-healing wound, ulcer, or bone fracture Presence of central nervous system or brain metastases History of other malignancies within 5 years of Day 0, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer Pregnant (positive pregnancy test) or lactating Inability to comply with study and follow-up procedures Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julie Hambleton, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18024865
    Citation
    Cannistra SA, Matulonis UA, Penson RT, Hambleton J, Dupont J, Mackey H, Douglas J, Burger RA, Armstrong D, Wenham R, McGuire W. Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. J Clin Oncol. 2007 Nov 20;25(33):5180-6. doi: 10.1200/JCO.2007.12.0782. Erratum In: J Clin Oncol. 2008 Apr 1;26(10):1773.
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    A Study of Bevacizumab in Ovarian Cancer or Primary Peritoneal Cancer Where Doxil or Topotecan Therapy Has Failed

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